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UNITED STATES DISTRICT COURT

FOR THE WESTERN DISTRICT OF PENNSYLVANIA

UNITED STATES OF AMERICA,

Plaintiff,

PHILIPS RS NORTH AMERICA LLC,

RESPIRONICS CALIFORNIA LLC, and

PHILIPS HOLDING USA INC.,

corporations, and ROY JAKOBS, STEVEN

B. C DE BACA, THOMAS FALLON,

DANIEL LEONARD, and JEFF DILULLO,

individuals,

Defendants.

No.

CONSENT DECREE OF PERMANENT

INJUNCTION

Plaintiff, the United States of America, by its undersigned attorneys, having filed a

Complaint for Permanent Injunction against Philips RS North America LLC, Respironics

California LLC, and Philips Holding USA Inc., corporations, and Roy Jakobs, Steven B. C de

Baca, Thomas Fallon, Daniel Leonard, and Jeff DiLullo, individuals (collectively,

“Defendants”), and Defendants, without admitting the allegations in the Complaint, having

appeared and having consented to entry of this Decree without contest and before any testimony

has been taken, and the United States of America having consented to this Decree,

IT IS HEREBY ORDERED, ADJUDGED, AND DECREED AS FOLLOWS:

1. This Court has jurisdiction over the subject matter of this action pursuant to 28

U.S.C. §§ 1331, 1337, and 1345, and 21 U.S.C. § 332, and has personal jurisdiction over all

parties. Venue is proper in this district under 28 U.S.C. § 1391(b) and (c).

2. The Complaint for Permanent Injunction states a cause of action against

Defendants under the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. §§ 301-399i.

3. For purposes of this Decree, the following definitions shall apply:

:24-cv-505-RJC

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A. “Actionable Registration” shall have the meaning set forth in the Recall

Remediation Plan (as defined in subparagraph 3.V. below).

B. “Affiliated Legal Entity” means in relation to Defendant Entities (as

defined in subparagraph 3.G. below), any legal entity which directly or indirectly: (i) owns or

controls a Defendant Entity; (ii) is owned or controlled by a Defendant Entity; or (iii) is owned

or controlled by the legal entity owning or controlling a Defendant Entity, but any such legal

entity will only be considered an Affiliated Legal Entity for as long as such ownership or control

exists. For the purpose of this definition, a legal entity will be deemed to be controlled if:

(i) more than 50% (fifty percent) of its voting stock is owned by the controlling entity; or (ii) the

controlling entity has the ability to direct the business activities or appoint the majority of the

directors of such legal entity. Defendants shall provide FDA (as defined in subparagraph 3.K.

below) with documentation showing whether an entity is an Affiliated Legal Entity within the

meaning of this paragraph, within seven (7) days of receiving a written request for such

documentation.

C. “Associated Persons” means Defendants’ directors, officers, agents,

representatives, employees, attorneys, successors, and assigns, and any and all persons in active

concert or participation with any of them (including, but not limited to, individuals, partnerships,

corporations, subsidiaries, franchisees, affiliates, and “doing business as” entities).

D. “Covered Respironics Facilities” means: (i) 1001 and 1010 Murry Ridge

Lane, Murrysville, PA 15668 (“Murrysville Facility”); (ii) 312 Alvin Drive, New Kensington,

PA 15068; (iii) 174 Tech Center Drive, Mount Pleasant, PA 15666 (“Mount Pleasant Facility”);

(iv) 6501 Living Place, Pittsburgh, PA 15206; and (v) 2271 Cosmos Court, Carlsbad, CA 92011

(“Carlsbad Facility”). Defendants represent to this Court that the Carlsbad Facility ceased

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manufacturing Devices (as defined in subparagraph 3.I. below) on or before December 31, 2022

and that they withdrew the establishment registration for that facility on or before January 31,

2023. If Defendants determine to resume manufacturing (as defined in subparagraph 3.P. below)

at the Carlsbad Facility or transfer manufacturing operations from the Carlsbad Facility to

another facility owned or operated by Defendants or an Affiliated Legal Entity, then they shall

give notice to FDA and such facility shall become subject to all the provisions of this Decree

applicable to the Covered Respironics Facilities. Defendants may not transfer any Device

manufacturing operations at a Covered Respironics Facility to a facility owned by an Affiliated

Legal Entity unless the owner of the transferee facility agrees to become a party to this Decree

with regard to the transferred Device manufacturing operations and this Decree has been

amended to reflect that agreement.

E. “Days” means calendar days, unless otherwise specified.

F. “Defendants’ Devices” means all Devices manufactured at the

Defendants’ Facilities (as defined in subparagraph 3.H. below).

G. “Defendant Entities” means (i) Philips RS North America LLC (“Philips

Respironics”), (ii) Respironics California LLC, and (iii) Philips Holding USA Inc.

H. “Defendants’ Facilities” means (i) the Covered Respironics Facilities; (ii)

the Other SRC Facilities (as defined in subparagraph 3.S. below); (iii) any facility where Rework

(as defined in subparagraph 3.Y. below) operations on Defendants’ Devices to effectuate Recalls

RES 88058 and RES 88071 have taken or are taking place; and (iv) any facility added to this

Decree pursuant to paragraph 22. However, this Decree does not apply to Devices manufactured

at any Defendants’ Facility to the extent that those Devices are subject to the 2017 Consent

Decree (as defined in subparagraph 3.CC. below). A facility performing Rework operations as

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described in clause (iii) of this subparagraph that is not owned or operated by the Defendant

Entities is a Defendants’ Facility for purposes of this Decree only with respect to its Rework

operations on behalf of the Defendant Entities, and such a facility and the Devices manufactured

therein other than the Rework Devices (as defined in subparagraph 3.Z. below) are otherwise not

within the scope of this Decree.

I. “Device” shall have the meaning given to the term in 21 U.S.C.

§ 321(h)(1) and shall include service/repair kits that may be used to manufacture the Rework

Devices.

J. “Discontinued Devices” shall include all Devices that were formerly

manufactured at any of the Covered Respironics Facilities that are no longer being manufactured

for United States distribution. Defendants shall submit a list of the Discontinued Devices to

FDA within ten (10) days of entry of this Decree.

K. “FDA” means the United States Food and Drug Administration.

L. “Form FDA 483” means the list of inspectional observations provided by

an FDA investigator at the close of an inspection.

M. “Good-Faith Attempt Process” shall have the meaning set forth in the

Recall Remediation Plan.

N. “Individual Defendants” means (i) Roy Jakobs, (ii) Steven B. C de Baca,

(iii) Thomas Fallon, (iv) Daniel Leonard, and (v) Jeff DiLullo.

O. “Long-Term Remediation Watch” shall have the meaning set forth in the

Recall Remediation Plan.

P. “Manufacture” or “Manufacturing” or “Manufacturing operations”

includes designing, manufacturing, fabricating, packing, assembling, processing, contract

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sterilizing, installing, labeling, relabeling, remanufacturing, reworking, repacking, and

specification development.

Q. “Medically Necessary Devices” means those Devices that FDA has

determined to be medically necessary. At the time the Decree is entered, FDA considers the

Devices listed in Appendix 2 to be Medically Necessary Devices. Following entry of this

Decree, FDA may add or remove Devices from this definition in accordance with the procedures

described in paragraph 8.A.

R. “New Foam” means the sound abatement foam used to replace or used in

lieu of the PE-PUR (as defined in subparagraph 3.T. below) sound abatement foam.

S. “Other SRC Facilities” means all facilities (other than the Covered

Respironics Facilities) at which Defendants’ Sleep and Respiratory Care Business (as defined in

subparagraph 3.AA. below) manufactures or services Devices on the date of entry of this Decree

or any time thereafter, including, but not limited to, the facilities identified in Appendix 1.

Defendants may not transfer any Sleep and Respiratory Care Business Device manufacturing

operations from an Other SRC Facility to a facility owned or operated by an Affiliated Legal

Entity unless the owner of the transferee facility agrees to become a party to this Decree with

regard to the transferred Sleep and Respiratory Care Business Device manufacturing operations

and this Decree has been amended to reflect that agreement by adding the facility to Appendix 1.

If all of the Sleep and Respiratory Care Business operations and Devices are discontinued at a

facility that is an Other SRC Facility on the date of entry of this Decree, that facility will no

longer be considered an Other SRC Facility. Defendants represent to this Court that, as of the

date of entry of this Decree, the facility located at 5905 Nathan Lane North, Suite 200, Plymouth,

MN does not manufacture any SRC Devices (as defined in subparagraph 3.BB. below); and the

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facility located at 920 SW Emkay Drive, Suite 100, Bend, OR ceased manufacturing Devices

and Defendants have withdrawn the establishment registration for that Oregon facility.

T. “PE-PUR” means polyester-based polyurethane.

U. “Recall Remediation Devices” means the Replacement Devices (as

defined in subparagraph 3.X. below), the Rework Devices, and the service/repair kits used to

manufacture the Rework Devices.

V. “Recall Remediation Plan” means the plan submitted by Defendants to

FDA (version 5), as amended on March 28, 2024, and agreed to by FDA on March 28, 2024,

including any modifications thereto made in accordance with paragraph 12 of this Decree.

W. “Recalled Devices” means Devices that are subject to the Class I recalls

Defendant Philips Respironics initiated on June 14, 2021 (RES 88058 and RES 88071),

including any Devices that were or are added to one of those recalls after June 14, 2021.

X. “Replacement Devices” means any Devices manufactured, held, or

distributed by Defendants to permanently replace the Recalled Devices to effectuate Recalls RES

88058 and RES 88071 and the Recall Remediation Plan, including, but not limited to, versions of

the Recalled Devices that do not contain PE-PUR sound abatement foam.

Y. “Rework” means the process of removing PE-PUR sound abatement foam

from Recalled Devices and, where applicable, replacing that foam with New Foam.

Z. “Rework Devices” means Recalled Devices from which PE-PUR sound

abatement foam has been or will be removed by Defendants or their employees or agents, and,

where applicable, replaced with New Foam.

AA. “Sleep and Respiratory Care Business” includes the business that the

Defendant Entities identify as their “Sleep and Respiratory Care Business” on the date of entry

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of this Decree or any subsequent date, including, but not limited to, the manufacturing and

servicing of the Devices listed at Appendix 3 and any Devices that were manufactured or

serviced by the Sleep and Respiratory Care Business on July 18, 2022 or any subsequent date,

and any successor to the Sleep and Respiratory Care Business.

BB. “SRC Device” means any Device that, on the date of entry of this Decree

or any subsequent date, is manufactured or serviced by or for the Sleep and Respiratory Care

Business. “SRC Device” includes all Devices listed in Appendix 3, even if the manufacturing of

the Device is transferred to another facility owned or operated by a different business segment or

unit of the Defendant Entities or any of their subsidiaries or affiliates after entry of this Decree.

CC. “2017 Consent Decree” means the Consent Decree for Permanent

Injunction entered in United States v. Philips North America LLC d/b/a Philips Medical Systems

and Philips Healthcare, et al., Civ. No. 17-11955 (D. Mass.).

4. The Complaint alleges that Defendants violate the Act, 21 U.S.C. § 331(a), by

introducing or delivering for introduction into interstate commerce, or causing the introduction

or delivery for introduction into interstate commerce, articles of Device that are adulterated

within the meaning of 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls

used for, their manufacture, packing, storage, and installation are not in conformity with the

current good manufacturing practice (“CGMP”) requirements set forth in 21 C.F.R. Part 820.

5. The Complaint alleges that Defendants violate the Act, 21 U.S.C. § 331(a), by

introducing or delivering for introduction into interstate commerce, or causing the introduction

or delivery for introduction into interstate commerce, articles of Device that are misbranded

within the meaning of 21 U.S.C. § 352(t) in that Defendants failed or refused to furnish material

or information respecting the Devices, as required by 21 C.F.R. Part 806.

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6. The Complaint alleges that Defendants violate 21 U.S.C. § 331(k), by causing

Devices to become adulterated within the meaning of 21 U.S.C. § 351(h) and/or misbranded

within the meaning of 21 U.S.C. § 352(t), while such Devices are held for sale after shipment of

one or more of their components in interstate commerce.

PROVISIONS APPLICABLE TO DEVICES MANUFACTURED

AT THE COVERED RESPIRONICS FACILITIES

7. Upon entry of this Decree, Defendants and each and all of their Associated

Persons, who have received actual notice of this Decree by personal service or otherwise, are

permanently restrained and enjoined, pursuant to 21 U.S.C. § 332(a), from directly or indirectly

manufacturing, holding, and/or distributing any Device at or from Covered Respironics

Facilities, unless and until:

A. Defendants have completed the repair/Rework, replacement, and refund

activities set forth in the Recall Remediation Plan in accordance with the recall effectiveness

targets set forth in the Recall Remediation Plan;

B. The facilities, and the methods and controls used to manufacture, hold,

and distribute Devices at or from the Covered Respironics Facilities are established, operated,

and administered in compliance with 21 U.S.C. § 351(h) and 21 C.F.R. Parts 803, 806, and

820;

C. Defendants select and retain at their expense an independent person or

persons (the “QS Expert I”) to conduct inspections of the Covered Respironics Facilities and to

review Defendants’ procedures and methods for manufacturing, holding, and distributing

Devices, to determine whether their methods, facilities, and controls are operated and

administered in conformity with the Act, its implementing regulations, and this Decree. The QS

Expert I shall be qualified by education, training, and experience to conduct such inspections,

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have specific expertise in evaluating compliance with the requirements in 21 C.F.R. Parts 803,

806, and 820 and 21 C.F.R. § 807.81, and be without personal or financial ties (other than a

consulting agreement between the parties) to Defendants’ officers or employees or their

families. Defendants shall notify FDA in writing of the identity of the QS Expert I within ten

(10) days of entry of this Decree;

D. The QS Expert I develops a plan to inspect the Covered Respironics

Facilities and the methods and controls used to manufacture, hold, and distribute Devices at the

Covered Respironics Facilities (the “Work Plan”), which shall include a timetable for completion

of those inspections, and submits the Work Plan to FDA for its review and written approval. The

plan shall be submitted to FDA no later than thirty (30) days after entry of this Decree. The QS

Expert I shall not implement the Work Plan prior to receiving FDA’s written approval, and in no

circumstance shall FDA’s silence be construed as a substitute for written approval;

E. At Defendants’ election, the QS Expert I may develop separate Work

Plans for each of the Covered Respironics Facilities and submit such Work Plans separately to

FDA;

F. After receiving FDA’s written approval of the Work Plan, the QS

Expert I performs comprehensive inspections of the Covered Respironics Facilities and submits

a report concurrently to FDA and Defendants certifying in writing (i) that the QS Expert I has

inspected the Covered Respironics Facilities, and the methods and controls used to manufacture,

hold, and distribute Devices at such Covered Respironics Facilities; (ii) whether Defendants

have adequately corrected all observations set forth in FDA’s Form FDA 483 from the most

recent FDA inspection of each facility; (iii) whether, based upon those inspections, Defendants’

Covered Respironics Facilities, methods, and controls are operated in conformity with the Act,

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its implementing regulations, and this Decree; (iv) whether Defendants have adequate

procedures in place to ensure that they submit to FDA all medical device reports (“MDRs”),

establish and maintain MDR event files, and conduct an investigation and evaluate the cause of

each MDR event, in accordance with 21 C.F.R. Part 803; and (v) whether Defendants have

adequate procedures in place to ensure that they report to FDA actions concerning Device

corrections and removals, and maintain records of all corrections and removals regardless of

whether such corrections and removals are required to be reported to FDA, in accordance with

21 C.F.R. Part 806. The QS Expert I shall submit the report concurrently to FDA and to

Defendants, and the report shall include an evaluation of:

(i) Defendants’ compliance with 21 U.S.C. § 351(h) and 21 C.F.R.

Parts 803, 806, and 820;

(ii) Whether Defendants have established a plan that will provide

appropriate data that demonstrate all Devices manufactured at the Covered Respironics

Facilities meet all their design specifications throughout the entire service-life of the Device as

reflected in its labeling and design records;

(iii) Defendants’ procedures for their Corrective and Preventative

Action (“CAPA”) system, including, but not limited to: analyzing quality data to identify

existing and potential causes of nonconforming product and other quality problems;

investigating the causes of nonconformities relating to product, processes, and the quality

system; identifying the action(s) needed to correct and prevent recurrence of nonconforming

product and other quality problems; verifying or validating corrective and preventive actions to

ensure such actions are effective and do not adversely affect the finished Device; implementing

and recording changes in methods and procedures as needed to correct and prevent quality

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problems; ensuring that information related to quality problems or nonconforming product is

disseminated to those directly responsible for assuring the quality of such product or the

prevention of such problems; conducting and documenting adequate failure investigations; and

submitting relevant information on identified quality problems, as well as corrective and

preventive actions, for management review;

(iv) Defendants’ processing of all CAPAs and pre-CAPA

investigations since November 2021;

(v) Defendants’ procedures to control received, purchased, or

manufactured products to verify conformance to product specifications;

(vi) Defendants’ procedures to ensure all purchased or otherwise

received products and services conform to specified requirements;

(vii) Defendants’ design control system, including the design change

control process and performing risk analysis;

(viii) Defendants’ procedures for evaluating whether changes made to

the Devices manufactured at the Covered Respironics Facilities require the submission of a new

premarket notification;

(ix) Defendants’ procedures for receiving, reviewing, and evaluating

complaints and whether Defendants maintain accurate and complete complaint files;

(x) Defendants’ procedures for compliance with 21 C.F.R. Part 803

(medical device reporting);

(xi) Defendants’ procedures for compliance with 21 C.F.R. Part 806

(reports of corrections and removals); and

(xii) Other issues required by the Work Plan.

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For Discontinued Devices, QS Expert I’s inspection and reports shall be limited

to subclauses (iii), (iv), (ix), (x), and (xi) above. On the first day of the month, in the second

calendar month following FDA’s approval of the Work Plan and continuing until QS Expert I’s

completion of the Work Plan, the QS Expert I shall submit to FDA a status report on a quarterly

basis regarding QS Expert I’s execution of the Work Plan;

G. Defendants report to FDA in writing the actions that they have taken to:

(i) address all observations brought to Defendants’ attention by the QS Expert I and all

observations set forth in the Form FDA 483s for the Covered Respironics Facilities from the

most recent inspection of each facility; and (ii) ensure that the methods used in, and the facilities

and controls used for manufacturing, holding, and distributing Devices, reporting adverse

events, and reporting corrections and removals, are operated and administered and will be

continuously operated and administered in conformity with the Act, its implementing

regulations, and this Decree. Defendants shall include with their report a copy of a written

certification from the QS Expert I that Defendants are in compliance with the Act, its

implementing regulations, and this Decree. The QS Expert I may provide FDA with a separate

certification for each Covered Respironics Facility;

H. The Design Expert retained under paragraph 10 reviews the design of

the Replacement Devices and the Rework Devices to determine whether any changes have been

made to those Devices since the most recent clearance of each Device under 21 U.S.C. § 360(k)

to determine whether any such change requires the submission of a new premarket notification

or whether such changes have been otherwise authorized by FDA (e.g., pursuant to an FDA-

authorized Rework process for RES 88058 or RES 88071), and submits a report setting forth the

Design Expert’s findings concurrently to FDA and Defendants;

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I. FDA, as and when it deems necessary, inspects Defendants’ operations

to determine whether the requirements of this paragraph have been met, including whether the

Covered Respironics Facilities are operated in conformity with the Act, its implementing

regulations, and this Decree;

J. Defendants pay all costs and expenses incurred under paragraph 7 for

FDA inspections, investigations, supervision, reviews, examinations, and analyses, at the rates

set forth in paragraph 24 of this Decree; and

K. FDA notifies Defendants in writing that Defendants appear to be in

compliance with the requirements set forth in subparagraphs 7.A.-H. and J. of this Decree. In

no circumstance shall FDA’s silence be construed as a substitute for written notification.

8. Paragraph 7 shall not apply to the following:

A. Defendants’ manufacturing, processing, packaging, holding, or

distributing Devices, including any Device components, parts, or accessories, that are

Medically Necessary Devices listed at Appendix 2, which may be updated by FDA in

accordance with any of the following processes:

(i) FDA may on its own initiative add a new Device as a Medically

Necessary Device, by providing Defendants with written notification.

(ii) Defendants may request that a new Device be added to Appendix

2 as a Medically Necessary Device by submitting a request to FDA in writing, which shall

include the justification for the proposed addition. FDA will review the request and inform the

Defendants in writing of its determination, and in no circumstance shall FDA’s silence be

construed as a substitute for written approval.

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(iii) FDA may propose that a Device be removed from Appendix 2 by

submitting a notice to Defendants in writing, which shall include the justification for the

proposed deletion. Within fourteen (14) days of receipt of the written proposal, Defendants

shall provide to FDA either: (1) written notice that Defendants agree with the removal of the

Device from Appendix 2, in which case Defendants shall provide to FDA a written plan to

effectuate the removal within ten (10) days after submission of Defendants’ notice to FDA; or

(2) written notice that Defendants disagree, including a written rationale for why Defendants

believe the Device proposed for removal should remain on Appendix 2 as a Medically

Necessary Device. FDA will review Defendants’ notice and inform the Defendants in writing

of its determination. If FDA confirms the removal of the Device from Appendix 2, Defendants

shall provide to FDA a written plan to effectuate the removal within ten (10) days after receipt

of FDA’s written notice of the deletion. In no circumstance shall FDA’s silence be construed

as a substitute for written approval.

(iv) The determination of whether a Device should be added to or

deleted from Appendix 2 is committed to FDA’s sole discretion and is not subject to judicial

review.

B. Defendants’ manufacturing, processing, packaging, holding, or exporting

Devices, including any Device components, parts, or accessories, that are intended solely for

export from the United States, provided that:

(i) The Devices are not Recall Remediation Devices, unless (1) all

registered U.S. patients who could be remediated with the specific Recall Remediation Device

model to be exported and who were determined to have had an Actionable Registration at least

forty-five (45) days prior to entry of this Decree have been remediated; (2) at the time of

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export, for the immediate prior month, Defendants have met all the timeframes in the Recall

Remediation Plan for determining whether patients have an Actionable Registration,

performing the Good-Faith Attempt Process, and creating and fulfilling orders for patients with

Actionable Registrations for all registered U.S. patients who could be remediated with the

specific Recall Remediation Device model to be exported; and (3) Defendants have in stock a

sufficient number of Devices to address the projected remediation demand in the U.S. for such

Recall Remediation Device model for the next twelve months;

(ii) Defendants identify all Devices to be exported with a specific

code, number, or identifier along with the serial and lot numbers that readily identify the

Devices as intended solely for export;

(iii) Defendants establish controls and documentation for all Devices

to be exported to assist with the monitoring and tracking of the exported Devices and to prevent

their reimportation into the United States, except for the purpose of a failure investigation by

Defendants to investigate a complaint;

(iv) Defendants provide FDA with an action plan Defendants intend

to implement in the event that Defendants become aware of a customer or supplier that has

attempted to import, or has imported, into the United States a Device that was intended for

export only; and

(v) The requirements of 21 U.S.C. § 381(e) or 21 U.S.C. § 382 are

met.

C. Defendants’ manufacturing, processing, packaging, holding, or

distributing Devices, including any Device components, parts, or accessories, that:

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(i) Are provided by Defendants to testing laboratories solely for the

purpose of development, testing, verification, validation, or qualification activities necessary to

complete: (1) the Recall Remediation Plan or any other activity required under this Decree; (2)

evaluation of the potential health risks associated with the Recalled Devices or any activity

intended to support ongoing civil litigation related to the Recalled Devices; (3) designs and

design changes or modifications in accordance with 21 C.F.R. Part 820 or comparable

international standards or requirements; (4) changes to production, process controls,

manufacturing procedures, or production or manufacturing-related equipment; (5) complaint

investigations and corrective and preventive actions and investigations; (6) changes to

components, raw materials, parts, suppliers, or supplier processes or services; or (7) preparation

of a premarket submission to FDA or comparable foreign regulatory authority or notified body;

(ii) Are intended solely to implement a correction or removal action

to reduce, mitigate, or eliminate a risk to health or remedy a potential violation, provided that

Defendants: (1) notify FDA within ten (10) business days of initiating such correction or

removal under 21 C.F.R. Part 806, unless exempt from such notification requirements, and (2)

cease the removal or correction, and/or the manufacturing, processing, packaging, labeling,

holding, and/or distribution of the Devices required for such correction or removal, including

any component, part or accessory, if FDA so instructs in writing. If Defendants’

implementation of any such correction or removal requires export of Recall Remediation

Devices, the export amount of each model of a Recall Remediation Device shall not exceed the

amount proportionate to the ex-U.S. market share for such Device model, unless Defendants

have in stock a sufficient number of Recall Remediation Devices to address the projected

remediation demand in the U.S. for such Recall Remediation Device model for the next twelve

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months, in which case the export amount to implement the correction or removal shall not

exceed the excess Recall Remediation Devices for that model in addition to the proportionate

ex-U.S. market share. For purposes of this provision, “ex-U.S. market share” means the ex-

U.S. percentage of total unit sales in the full year preceding June 1, 2021;

(iii) Are intended solely for the purpose of: (1) conducting any

clinical investigations and testing in accordance with 21 C.F.R. Part 812; or (2) exporting

Devices for use in clinical investigations performed outside of the United States provided that

Defendants also satisfy all of the conditions in subparagraph 8.B.;

(iv) Are intended solely for the purpose of performing routine service

or maintenance on, or are intended as a service replacement or service loaner for, Devices that

are in the possession of customers and consignees of Defendants or other users, or are

consumables, accessories, or replacement parts intended to support the use of Devices in the

possession of customers or other users, as set forth at Appendix 4;

(v) Are intended solely for use in nonclinical research (including

bench testing, market research, validation, human factors, and animal testing) or other non-

human or nonclinical use, provided that Defendants label such Devices as “For [Research

Use/Animal Use/Demonstration/Validation Testing] Only – Not for Human or Clinical Use”

and they are used in a manner that does not involve use on human beings; or

(vi) Have been requested by Defendants in writing pursuant to this

subparagraph, provided that: (1) Defendants submit to FDA the documentation and justification

for such request that FDA deems necessary; and (2) the Defendants’ request has been granted

by FDA in writing. In no circumstance shall FDA’s silence be construed as a substitute for

written approval.

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D. Defendants’ manufacturing, processing, packaging, or holding (but not

distributing) Devices in anticipation of FDA’s approval, clearance, or de novo authorization for

a new or modified Device, including, without limitation, design and development work for new

or modified Devices. Defendants understand and agree that any Devices manufactured under

this subparagraph shall be destroyed, at Defendants’ sole expense, in the event FDA determines

that the Devices are not approved, cleared, or authorized, unless FDA, in writing, waives

destruction of such Devices to permit a resubmission by the Defendants to achieve such

approval, clearance, or authorization.

E. Defendants’ importing and distributing Devices that are components,

parts, or accessories necessary to manufacture, repair/Rework, or process any Device that

Defendants are permitted to manufacture, repair/Rework, or process under this Decree.

F. Defendants’ holding at the Mount Pleasant Facility Devices that were not

manufactured, processed, or packaged at any of the Covered Respironics Facilities and

distributing such Devices from the Mount Pleasant Facility.

ADDITIONAL PROVISIONS APPLICABLE TO THE RECALL

REMEDIATION DEVICES AND THE RECALL REMEDIATION PLAN

9. Defendants shall take the following additional steps regarding the New Foam

used in certain Recall Remediation Devices:

A. Within ten (10) days of entry of this Decree, Defendants shall select and

retain at their expense an independent person (or persons) who is qualified by education,

training, and experience to review and evaluate the testing data and analyses described in

subparagraph 9.B. and who is without personal or financial ties (other than a consulting

agreement between the parties) to Defendants’ officers or employees or their families (the

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 18 of 73

“Testing Expert”). Defendants shall notify FDA in writing of the identity of the Testing Expert

within five (5) days of retaining such expert;

B. Within ninety (90) days of entry of this Decree, the Testing Expert shall

review and evaluate Defendants’ plan for assuring the safety of the New Foam they are using to

manufacture the Replacement Devices and the Rework Devices to assess whether the testing that

has already been performed on the New Foam, coupled with the testing that is in process and

planned, will enable a determination that the New Foam does not degrade during the labeled

service life of the Device and addresses all other risks posed by PE-PUR sound abatement foam

without introducing new or similar health concerns;

(i) The Testing Expert’s review and evaluation shall include review of

the protocols for and, where available, results for the following types of testing and analysesto

evaluate the biocompatibility of Replacement Devices and Rework Devices containing New

Foam used in breathing gas pathways in healthcare applications:

(1) biocompatibility evaluation and risk management review

from exhaustive testing under worst case conditions of Replacement Devices and Rework

Devices containing New Foam that would be representative testing for the duration of the labeled

service life of the Device, per ISO 18562-1, including:

(a) biocompatibility hazard identification per clause 4.3

of ISO 18562-1, which includes consideration of the New Foam materials of manufacture,

intended additives, process contaminants and residues, substances released in normal use,

degradation products from normal use that might pass into the patient via the gas pathways

(including consideration of clinically relevant use case scenarios such as low and high

environmental temperatures, low and high environmental humidity, extended hours of use, or

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 19 of 73

other clinically relevant use cases that may affect the stability of the New Foam); physical

characteristics of the New Foam material; and the effects of any hygienic processing steps

required before use or re-use, to the extent that a cleaning method is consistent with the Device

labeling;

(b) risk assessment of Devices containing New Foam

per clause 4.4 of ISO 18562-1; and

containing New Foam per clause 4.5 of ISO 18562-1;

(2) analytical and toxicological risk assessments of volatile

organic compounds (“VOCs”) emission from Replacement Devices and Rework Devices

containing New Foam per ISO 18562-1 and ISO 18562-3;

(3) particulate matter (“PM”) testing of Replacement Devices

and Rework Devices containing New Foam per ISO 18562-1 and ISO 18562-2; and

(4) to the extent that the considerations of subclauses (1)-(3)

are not sufficiently mitigated by testing and/or justifiable scientific rationale, such that plausible

scenarios exist whereby the New Foam may degrade and a patient may come into direct contact

with measurable amounts of particulates from such degraded New Foam, chemical

characterization and biological evaluation of the New Foam per ISO 10993;

(ii) The Testing Expert shall submit a report summarizing the Testing

Expert’s evaluation to Defendants and FDA concurrently, within thirty (30) days of completion

of the review and evaluation described in clause (i) of subparagraph 9.B. If the Testing Expert

does not believe the testing and analyses that Defendants have performed, coupled with the

testing and analyses that are in process and planned, will enable a determination whether the

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New Foam does not degrade during the labeled service life of the Device and addresses all other

risks posed by PE-PUR sound abatement foam that led to RES 88058 and RES 88071 without

introducing new or similar health concerns, the Testing Expert shall identify specific gaps and

proposed testing, analyses, or other information or activities that Defendants shall perform or

provide to enable such a determination. The copy of the report submitted by the Testing Expert

to FDA shall be accompanied by a copy of all protocols, reports, results, and data that the

Testing Expert reviewed as part of the Testing Expert’s evaluation;

(iii) If the Testing Expert identifies gaps and proposes testing, analyses,

or other information or activities pursuant to clause (ii) of subparagraph 9.B., within ninety (90)

days of receipt of the report, Defendants shall submit to FDA a plan for addressing such gaps and

the proposed testing, analyses, or other information or activities, to the Testing Expert’s

satisfaction, and a timetable for completion of those activities. The timetable shall be subject to

FDA approval. Defendants shall ensure the implementation and completion of the testing,

analyses, or other information or activities proposed by the Testing Expert in accordance with

the FDA-approved timetable;

(iv) Within ninety (90) days of the completion of the testing and

analyses described in clause (i) of subparagraph 9.B. (including any testing or analyses ongoing

or planned at the time of the Testing Expert’s initial review and evaluation), and any additional

testing, analyses, or other information or activities to address the Testing Expert’s findings

pursuant to clause (ii) of subparagraph 9.B., the Testing Expert shall submit concurrently to FDA

and to Defendants the Testing Expert’s determination whether the New Foam used in the

Replacement Devices and Rework Devices does not degrade during the labeled service life of the

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Device and addresses all other risks posed by the PE-PUR sound abatement foam that led to RES

88058 and RES 88071 without introducing new or similar health concerns; and

(v) After reviewing the Testing Expert’s report, FDA will notify

Defendants whether they appear to have ensured the New Foam used in the Replacement

Devices and Rework Devices does not degrade during the labeled service life of the Device and

addresses all risks posed by the PE-PUR sound abatement foam that led to RES 88058 and RES

88071 without introducing new or similar health concerns.

10. Within ten (10) days of entry of this Decree, Defendants shall select and retain at

their expense an independent person (or persons) who is qualified by education, training, and

experience to review and evaluate the design information and data described in subparagraphs

7.H. and 10.A. and who is without personal or financial ties (other than a consulting agreement

between the parties) to Defendants’ officers or employees or their families (the “Design

Expert”). Defendants shall notify FDA in writing of the identity of the Design Expert within five

(5) days of retaining such expert. The Design Expert shall take the following additional steps

regarding the Recall Remediation Devices:

A. The Design Expert shall review the design of the Recall Remediation

Devices (with the exception of the safety of the New Foam, which is to be reviewed separately

under paragraph 9) to determine whether those Devices have undergone appropriate and

necessary testing; their designs have undergone a thorough risk analysis; and their designs have

been properly verified and validated. Within sixty (60) days of entry of this Decree (or, for

Recall Remediation Devices added after entry of this Decree, within sixty (60) days after such

Recall Remediation Devices are authorized by FDA and added to the Recall Remediation Plan

per paragraph 12 of this Decree), the Design Expert shall submit concurrently to FDA and

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Defendants a report with the Design Expert’s preliminary assessment of the design of the Recall

Remediation Devices and a work plan for the remainder of its review, if the Design Expert

determines that the review requires more than sixty (60) days to complete. Once the Design

Expert’s review is complete, the Design Expert shall submit concurrently to FDA and

Defendants either: (i) a certification that the Recall Remediation Devices have undergone

appropriate and necessary testing, the designs of the Recall Remediation Devices have

undergone a thorough risk analysis, and their designs have been properly verified and validated;

or (ii) a report identifying necessary corrective actions;

B. If the Design Expert identifies the need for corrective actions, within thirty

(30) days of the submission of the report, Defendants shall submit a written report to FDA that

details the specific corrective actions Defendants will take and a timetable to address any

deficiencies identified by the Design Expert. The timetable shall be subject to FDA approval.

Defendants shall ensure the implementation of the corrective actions detailed in the report;

C. As the corrective actions detailed in the report described in

subparagraph 10.B. are completed, Defendants shall notify the Design Expert. The Design

Expert shall promptly inspect and verify whether those actions have been completed to the

Design Expert’s satisfaction and in accordance with the timetable approved by FDA. If the

Design Expert determines that an action has not been completed to the Design Expert’s

satisfaction, the Design Expert promptly will so notify Defendants. Upon FDA approval of the

timetable under subparagraph 10.B., and thereafter on the first day of each month, the Design

Expert shall submit concurrently to FDA and Defendants a table that succinctly summarizes the

Design Expert’s findings regarding whether the actions have been completed to the Design

Expert’s satisfaction and in accordance with the timetable approved by FDA;

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D. FDA may, in its discretion and without prior notice, periodically inspect

the Covered Respironics Facilities and undertake such additional examinations, reviews, and

analyses to verify whether the actions reported to have been completed have in fact been

completed in a satisfactory manner. If FDA determines that an action that has been reported to

be completed is inadequate, FDA will notify Defendants in writing, and Defendants shall take

appropriate action in accordance with a timetable that is subject to approval by FDA; and

E. When the Design Expert determines that all the corrective actions

identified in the timetable approved by FDA pursuant to subparagraph 10.B. have been

completed to the Design Expert’s satisfaction, the Design Expert shall provide Defendants with a

written certification that all of the actions have been completed. Once the certification has been

issued, Defendants shall promptly submit the Design Expert’s certification to FDA.

11. Defendants shall take the following steps to ensure their manufacture of the

Rework Devices complies with the Act, 21 C.F.R. Part 820, and this Decree:

A. Within five (5) days of entry of this Decree, Defendants shall select and

retain at their expense an independent person or persons (the “QS Expert II”), to perform an

evaluation of Defendants’ Facilities, methods, and controls for manufacturing, holding, and

distributing the Rework Devices and to determine whether Defendants’ Facilities, methods, and

controls for manufacture of the Rework Devices are operated and administered in conformity

with the Act, its implementing regulations, and this Decree;

B. The QS Expert II shall be qualified by education, training, and experience

to conduct such inspections, have specific expertise in evaluating compliance with the CGMP

requirements for Devices as set forth in 21 C.F.R. Part 820, be without personal or financial ties

(other than a consulting agreement between the parties) to Defendants’ officers or employees or

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 24 of 73

their families, and may, if Defendants choose, be the same person or persons described as the QS

Expert I in subparagraph 7.C. Defendants shall notify FDA in writing of the identity of the QS

Expert II within five (5) days of retaining such expert;

C. Within sixty (60) days of retaining a QS Expert II, the QS Expert II shall

complete inspections of Defendants’ manufacturing operations related to the Rework Devices at

all Defendants’ Facilities where Rework operations are taking place, and report to Defendants

and FDA in writing whether the methods for manufacturing, holding, and distributing the

Rework Devices are operated and administered in conformity with 21 C.F.R. Part 820; provided,

however, that QS Expert II’s inspections shall not include any Defendants’ Facility that was

inspected by FDA within one-hundred eighty (180) days prior to the entry of this Decree if such

FDA inspection did not result in any Form FDA 483 observations. This review shall include

evaluation of the supplier controls used by Defendants for any contractors or suppliers

performing any manufacturing operations for the Rework Devices;

D. Within thirty (30) days of receipt of the QS Expert II’s report, Defendants

shall submit a written report to FDA that details the specific corrective actions Defendants will

take and a timetable to address any deficiencies identified by the QS Expert II. The timetable

shall be subject to FDA approval. Defendants shall ensure the implementation of the corrective

actions detailed in the report in accordance with the approved timetable;

E. As the corrective actions detailed in the report described in

subparagraph 11.D. are completed, Defendants shall notify the QS Expert II. The QS Expert II

shall promptly inspect and verify whether those actions have been completed to the QS

Expert II’s satisfaction and in accordance with the timetable approved by FDA. If the QS

Expert II determines that an action has not been completed to the QS Expert II’s satisfaction, the

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QS Expert II promptly will so notify Defendants. Upon FDA approval of the timetable under

subparagraph 11.D., and thereafter on the first day of each month, the QS Expert II shall submit

concurrently to FDA and Defendants a table that succinctly summarizes the QS Expert II’s

findings regarding whether the corrective actions have been completed to the QS Expert II’s

satisfaction and in accordance with the timetable approved by FDA;

F. FDA may, in its discretion and without prior notice, periodically inspect

Defendants’ Facilities where Rework operations are taking place and undertake such additional

examinations, reviews, and analyses to verify whether the actions reported to have been

completed have in fact been completed in a satisfactory manner. In the event that FDA

determines that an action that has been reported to be completed is inadequate, FDA will notify

Defendants in writing, and Defendants shall take appropriate action in accordance with a

timetable that is subject to approval by FDA; and

G. When the QS Expert II determines that all of the corrective actions

identified in the timetables approved by FDA pursuant to subparagraphs 11.D. and 11.F. have

been completed to the QS Expert II’s satisfaction, the QS Expert II shall provide Defendants and

FDA with a written certification that all the actions have been completed and that Defendants’

facilities, methods, and controls for manufacture of the Rework Devices are operated and

administered in conformity with the Act, its implementing regulations, and this Decree.

12. Defendants shall complete the repair/Rework, replacement, and refund activities

set forth in the Recall Remediation Plan, and implement the Recall Remediation Plan, in

accordance with the recall effectiveness targets set forth in the Recall Remediation Plan.

A. In the event Defendants determine that a change to the Recall Remediation

Plan is required to continue to effectively and efficiently implement the repair/Rework,

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 26 of 73

replacement, refund, or other related recall activities for RES 88058 or RES 88071, Defendants

shall provide notice to FDA in their ongoing bi-weekly meetings with FDA (or any successor

communication agreed to by Defendants and FDA) as documented in written minutes provided

by Defendants to FDA after each bi-weekly meeting and in written notice. If FDA has

comments on or objections to the proposed revisions to the Recall Remediation Plan, FDA will

provide written notice to Defendants within thirty (30) days of receipt of notice of the proposed

revisions, and Defendants shall address those comments and objections, and submit a revised

proposed plan to FDA for review within thirty (30) days of receipt of FDA’s comments. In no

circumstance shall FDA’s silence be construed as a substitute for written approval of the

proposed changes. After receiving FDA’s written approval of the revised plan, Defendants shall

continuously implement the plan until they have completed the repair/Rework, replacement, and

refund activities set forth in the Recall Remediation Plan in accordance with the recall

effectiveness targets set forth in the Recall Remediation Plan.

B. If FDA determines, based on information that was not available or

provided to FDA prior to the approval of the Recall Remediation Plan or any change approved

pursuant to subparagraph 12.A., that additional actions are necessary to address the risks posed

by the Recalled Devices, FDA will notify Defendants in writing of its concerns and any

additional actions FDA believes are necessary. Defendants shall submit their written response to

FDA’s notice within thirty (30) days of receipt, including a description of any changes

Defendants propose to the Recall Remediation Plan to address FDA’s concerns. Within thirty

(30) days of receipt of the Defendants’ response, FDA will notify Defendants in writing whether

it approves the revised Recall Remediation Plan and, if not, of its comments and/or objections to

Defendants’ proposal. In no circumstance shall FDA’s silence be construed as a substitute for

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written approval. Defendants shall address FDA’s comments and/or objections, if any, within

ten (10) days of receipt. After receiving FDA’s written approval of the revised Recall

Remediation Plan, Defendants shall continuously implement the revised plan until they have

completed the repair/Rework, replacement, and refund activities set forth in the Recall

Remediation Plan in accordance with the recall effectiveness targets set forth in the Recall

Remediation Plan.

13. Defendants agree to pay to the United States Treasury a percentage of net revenue from

any sale of Medically Necessary Devices distributed solely pursuant to subparagraph 8.A. between the

date of entry of this Decree and the date that FDA issues the notification in subparagraph 7.K., at the

following rates: 10% (ten percent) of net revenue between entry of the Decree and December 31, 2024;

12% (twelve percent) of net revenue between January 1, 2025 and December 31, 2025; and thereafter

25% (twenty-five percent) of net revenue. Defendants shall make the payments required by this

paragraph annually by February 28th each year. The amounts paid under this paragraph shall be

determined by a qualified financial auditor, who shall be paid by Defendants, acceptable to Defendants

and FDA, and without former or current personal or financial ties to the Defendants or their immediate

families. Defendants shall cooperate fully with the financial auditor and provide all records requested

by the financial auditor to make the determination described in this paragraph. Defendants further

agree, upon written request by the government, to make all documents reviewed and prepared by the

financial auditor available to the government. The parties acknowledge and agree that any payment(s)

made under this paragraph is (are) not a fine, penalty, forfeiture, or payment in lieu thereof for any

purpose, and that such payment(s) is (are) an equitable remedy and not punitive.

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 28 of 73

PROVISIONS APPLICABLE TO ALL DEVICES

MANUFACTURED AT THE OTHER SRC FACILITIES

14. Within thirty (30) days of entry of this Decree, Defendants shall retain at their

expense an independent person or persons (the “QS Expert III”) to inspect each of the Other

SRC Facilities. The inspections required by this paragraph are intended to provide

information to Defendants and FDA and are not based on recent adverse inspection findings at

these facilities by FDA.

A. The qualifications of the QS Expert III shall be the same as those set

forth in subparagraph 7.C., and, if Defendants choose, may be the same person or persons

described as the QS Expert I identified in subparagraph 7.C. or the QS Expert II identified in

subparagraph 11.A. Defendants shall notify FDA in writing of the identity and qualifications

of the QS Expert III as soon as they retain such person or persons.

B. Defendants shall cause the QS Expert III to conduct comprehensive

inspections of the Other SRC Facilities to ensure that the methods, facilities, and controls used

to manufacture, hold, and distribute Defendants’ SRC Devices comply with the Act, its

implementing regulations, and this Decree. The inspections shall include, but not be limited

to, an evaluation of Defendants’ design control and CAPA procedures, supplier controls,

Defendants’ processing of all CAPAs in the two years prior to the date the inspection

commences, and compliance with 21 C.F.R. Parts 803 and 806. The inspections of all the

Other SRC Facilities shall be completed no later than two hundred seventy (270) days after

the date of entry of this Decree.

C. Within thirty (30) days of the completion of each inspection of one of

the Other SRC Facilities, the QS Expert III shall prepare a written report of the QS

Expert III’s inspection that certifies to FDA: (i) that the QS Expert III has inspected the

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 29 of 73

facility; and (ii) whether the methods, facilities, and controls used to manufacture, hold, and

distribute SRC Devices at that Other SRC Facility are in compliance with the Act, its

implementing regulations, and this Decree. The QS Expert III shall submit the inspection

report concurrently to Defendants and FDA.

D. Within thirty (30) days of receipt of the QS Expert III’s report of an

inspection of one of the Other SRC Facilities, Defendants shall submit a written report to FDA

that details the specific corrective actions Defendants will take and a timetable to address any

deficiencies identified by the QS Expert III. The timetable shall be subject to FDA approval,

and in no circumstance shall FDA’s silence be construed as a substitute for written approval.

Defendants shall ensure the implementation of the corrective actions detailed in the report.

E. As the corrective actions detailed in the reports described in

subparagraph 14.D. are completed, Defendants shall notify the QS Expert III. The QS

Expert III shall inspect and verify whether those actions have been completed to the QS

Expert III’s satisfaction and in accordance with the timetable approved by FDA. If the QS

Expert III determines that an action has not been completed to the QS Expert III’s satisfaction,

the QS Expert III promptly will so notify Defendants. Upon FDA approval of the timetable

under subparagraph 14.D., on a quarterly basis, the QS Expert III shall submit concurrently to

FDA and Defendants a table that succinctly summarizes the QS Expert III’s findings

regarding whether the actions have been completed to the QS Expert III’s satisfaction and in

accordance with the timetable approved by FDA.

F. When the QS Expert III determines that all of the corrective actions

identified in the timetable approved by FDA have been completed to the QS Expert III’s

satisfaction, the QS Expert III shall provide Defendants with a written certification that all of

the actions have been completed and that the specific Other SRC Facility, based on the

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 30 of 73

inspection and on the satisfactory completion of the actions identified under subparagraph

14.D., is in conformity with the Act, its implementing regulations, and this Decree. Once the

certification has been issued, Defendants shall promptly submit the QS Expert III’s

certification to FDA.

G. FDA may, in its discretion and without prior notice, inspect the Other

SRC Facilities and undertake such additional examinations, reviews, and analyses as FDA

deems appropriate to determine whether the methods, facilities, and controls used to

manufacture, hold, and distribute SRC Devices at Other SRC Facilities are in conformity with

the Act, its implementing regulations, and this Decree. If FDA determines that any of the

methods, facilities, and controls used to manufacture, hold, and distribute SRC Devices at the

Other SRC Facilities are not in conformity with the Act, its implementing regulations, and/or

this Decree, FDA will notify Defendants of the deficiencies it observed and take such other

action, if any, as FDA deems appropriate, including, but not limited to, the actions specified in

paragraph 18.

H. Within thirty (30) days of receiving a notification from FDA under

subparagraph 14.G., Defendants shall submit to FDA a plan of actions Defendants propose to

take and a timetable for correcting the deficiencies. The timetable shall be subject to FDA

approval. Defendants shall promptly correct all deficiencies noted by FDA in accordance

with the FDA-approved timetable and cause the QS Expert III to reinspect and either

(i) certify that the deficiencies have been corrected to assure that the facility is in conformity

with the Act, its implementing regulations, and this Decree, or (ii) notify Defendants that the

one or more deficiencies remain uncorrected. If one or more deficiencies have not been

corrected, Defendants and the QS Expert III shall notify FDA in writing, and after Defendants

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have addressed those deficiencies, the QS Expert III shall determine whether he/she may make

the certification. Defendants shall then submit the certification to FDA.

I. After reviewing the QS Expert III’s certification, FDA will notify

Defendants whether they appear to be in compliance with the requirements set forth in

subparagraphs 14.A.-F. and H.

J. Defendants shall maintain complete copies of the inspection reports and

all underlying data in separate files at the Other SRC Facilities and shall promptly make the

reports and underlying data available to FDA upon request.

15. In the event that Defendants fail, as determined either by the QS Expert III or

FDA, to satisfactorily complete one or more actions in the timetable approved by FDA

pursuant to subparagraph 14.D. or H., Defendants shall pay to the United States Treasury as

liquidated damages the sum of $10,000 per action, per business day, until the action is fully

implemented and completed to FDA’s satisfaction. The annual total amount of such

liquidated damages shall not exceed ten million dollars ($10,000,000.00) in any calendar year.

Defendants understand and agree that the liquidated damages specified in this paragraph are

not punitive in nature and that they do not in any way limit the ability of the United States of

America to seek, or the Court to impose, civil and criminal contempt remedies based on

conduct that may also form the basis for the payment of liquidated damages.

GENERAL PROVISIONS

16. Defendants shall retain an independent person or persons (the “Auditor”) at

Defendants’ expense to conduct audit inspections of the Covered Respironics Facilities and the

Other SRC Facilities. For the Covered Respironics Facilities, after Defendants have complied

with subparagraphs 7.A.-H. and J. and FDA has notified Defendants in writing pursuant to

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subparagraph 7.K., the Auditor shall conduct audit inspections once every six (6) months for a

period of two (2) years and then once every year thereafter, for a total of five (5) years. For the

Other SRC Facilities, after Defendants receive the notification pursuant to subparagraph 14.I.,

the Auditor shall conduct audit inspections not less than once every two (2) years for a period of

four (4) years from the date of entry of this Decree, for a total of not less than two (2) audit

inspections.

A. The Auditor shall be qualified by education, training, and experience to

conduct such inspections, have specific expertise in evaluating compliance with the requirements

for Devices set forth in 21 C.F.R. Parts 803, 806, and 820, be without personal or financial ties

(other than a consulting agreement entered into by the parties) to Defendants’ officers or

employees or their families, and may, if Defendants choose, be the same person or persons

described as the QS Expert I, QS Expert II, or QS Expert III.

B. At the conclusion of each audit inspection, the Auditor shall prepare a

written audit report (the “Audit Report”) analyzing whether Defendants’ operations are in

compliance with the Act, its implementing regulations, and this Decree, and identifying in detail

any deviations from the foregoing (“Audit Report Observations”). As part of every Audit

Report, except the first, the Auditor shall assess the adequacy of corrective actions taken by

Defendants to correct all previous Audit Report Observations. The Audit Reports shall be

delivered contemporaneously to Defendants and FDA, no later than twenty (20) days after the

date the audit inspections are completed.

C. If an Audit Report contains any adverse Audit Report Observations,

Defendants shall, within thirty (30) days of receipt of the Audit Report, correct those

observations, unless FDA notifies Defendants that a shorter time period is necessary. If, after

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receiving the Audit Report, Defendants believe that correction of any adverse Audit Report

Observation will take longer than thirty (30) days, Defendants shall, within ten (10) days of

receipt of the Audit Report, propose a schedule to FDA in writing for completing corrections

(“Correction Schedule”) and provide justification for the additional time. Defendants shall

complete their corrections within thirty (30) days, unless FDA approves the Correction Schedule

in writing, in which case Defendants shall complete all corrections according to the approved

Correction Schedule. Within thirty (30) days of Defendants’ receipt of an Audit Report, or

within the time period provided in a Correction Schedule approved by FDA, the Auditor shall

review the actions taken by Defendants to correct the adverse Audit Report Observation(s).

Within five (5) days of completing that review, the Auditor shall (i) report in writing to FDA

whether each of the adverse Audit Report Observations has been corrected, and (ii) if they have

not all been corrected, identify which adverse Audit Report Observations remain uncorrected,

and provide an assessment of the risks of the uncorrected items and recommended corrective

actions.

D. If any Audit Report identifies any adverse Audit Report Observations at

the Covered Respironics Facilities, FDA may, in its discretion, require that the auditing cycle be

extended or begin anew for up to two (2) years for such facilities. In addition, Defendants shall

maintain complete Audit Reports and all their underlying data in separate files at Defendants’

Facilities and shall promptly make the Audit Reports and underlying data available to FDA upon

request.

17. Upon entry of this Decree, Defendants and each and all of their Associated

Persons, who have received actual notice of this Decree by personal service or otherwise, are

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 34 of 73

permanently enjoined under the provisions of 21 U.S.C. § 332(a) from directly or indirectly

doing or causing to be done any act that:

A. Violates 21 U.S.C. § 331(a), by introducing or delivering for introduction

into interstate commerce, or causing the introduction or delivery for introduction into interstate

commerce, any Device that is (i) adulterated within the meaning of 21 U.S.C. § 351(h), or

(ii) misbranded within the meaning of 21 U.S.C. § 352(t);

B. Violates 21 U.S.C. § 331(k), by causing any Device, including any

component of any Device, to become (i) adulterated within the meaning of 21 U.S.C. § 351(h),

or (ii) misbranded within the meaning of 21 U.S.C. § 352(t), while such Device is held for sale

after shipment of one or more of its components in interstate commerce; and/or

C. Results in the failure to implement and continuously maintain the

requirements of this Decree.

18. If, at any time after this Decree has been entered, FDA determines, based on the

results of an inspection, the analysis of samples, a report or data prepared or submitted by

Defendants, the Design Expert, the QS Expert I, the QS Expert II, the QS Expert III, or the

Auditor, or any other information, that Defendants have violated the Act or its implementing

regulations or have failed to comply with any provision of this Decree, or that additional

corrective actions are necessary to achieve compliance with the Act, its implementing

regulations, or this Decree, FDA may, as and when it deems necessary, order Defendants in

writing to take appropriate actions, including, but not limited to, the following:

A. Cease manufacturing, holding, distributing, storing, and/or servicing

Defendants’ Devices;

B. Revise, modify, or expand any report(s) prepared pursuant to the Decree;

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 35 of 73

C. Submit additional notifications, reports, or any other materials or

information to FDA;

D. At Defendants’ sole expense, recall, repair, replace, or refund the purchase

price of adulterated or misbranded Defendants’ Devices, accessories, or components

manufactured, distributed, and/or sold by Defendants, or that are under the custody and/or

control of Defendants’ agents, distributors, customers, or consumers;

E. Issue a safety alert, public health advisory, and/or press release; and/or

F. Take any other corrective action(s) as FDA, in its discretion, deems

necessary to protect the public health or to bring Defendants into compliance with the Act, its

implementing regulations, and this Decree.

19. Subparagraph 18.A. shall not apply to the manufacturing, processing, packaging,

holding for sale, or introducing or delivering for introduction into interstate commerce of any

Device that is intended solely for export from the United States, provided that: (A) Defendants

identify all Devices to be exported with a specific code, number, or identifier along with the

serial and lot numbers that readily identifies the Device as intended solely for export;

(B) Defendants establish controls and documentation for all Devices to be exported to assist with

the monitoring and tracking of the exported products and to prevent their reimportation into the

United States, except for the purpose of a failure investigation by Defendants to investigate a

complaint; (C) Defendants provide FDA with an action plan Defendants intend to implement in

the event that Defendants become aware of a customer or supplier that has attempted to import,

or has reimported, into the United States a Device that was intended for export only; and (D) the

requirements of 21 U.S.C. §§ 381(e)(1) or 382 have been satisfied and documented with respect

to any such Device.

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 36 of 73

20. The following process and procedures apply to any order issued by FDA under

this Decree, except as provided in subparagraph 20.D. below:

A. Unless a different timeframe is specified by FDA in its order, within ten

(10) days after receiving an order, Defendants shall notify FDA in writing either that:

(i) Defendants are undertaking or have undertaken corrective action, in which event Defendants

also shall describe the specific actions taken or to be taken and the proposed schedule for

completing the actions; or (ii) Defendants do not agree with FDA’s order. If Defendants notify

FDA that they do not agree with FDA’s order, Defendants shall explain in detail and in writing

the basis for their disagreement; in doing so, Defendants also may propose specific alternative

actions and specific timeframes for achieving FDA’s objectives.

B. If Defendants notify FDA that they do not agree with FDA’s order, FDA

will review Defendants’ notification and thereafter, in writing, affirm, modify, or withdraw its

order, as FDA deems appropriate. If FDA affirms or modifies its order, it will explain the basis

for its decision in writing. This written notification shall constitute final agency action.

C. If FDA affirms or modifies its order, Defendants shall, upon receipt of

FDA’s order, immediately implement the order (as modified, if applicable). Defendants shall

continue to diligently implement FDA’s order while the matter is before the Court and unless

and until the Court reverses, stays, or modifies FDA’s order. Any review of FDA’s decision

under this paragraph shall be made in accordance with the terms set forth in paragraph 34.

D. The process and procedures set forth in subparagraphs 20.A.-C. shall not

apply to any order issued under paragraph 18 if such order states that, in FDA’s judgment, the

matter raises significant public health concerns. In such case, Defendants shall immediately and

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 37 of 73

fully comply with the terms of that order. Should Defendants seek to challenge any such order,

they may petition this Court for relief.

21. Any cessation of operations described in paragraphs 18 and 20 shall continue until

Defendants receive written notification from FDA that Defendants appear to be in compliance

with the Act, its implementing regulations, and this Decree. The costs of FDA inspections,

sampling, testing, travel time, and subsistence expenses to implement the remedies set forth in

paragraph 18 shall be borne by Defendants at the rates specified in paragraph 24.

22. FDA may order any facility owned or operated by one or more of the Defendant

Entities (including their subsidiaries) other than the Covered Respironics Facilities, the Other

SRC Facilities, and the facilities subject to the 2017 Consent Decree, that manufactures, services,

and/or distributes Devices in interstate commerce to be fully subject to the provisions of this

Decree as though the facility had been listed as an Other SRC Facility when the Decree was

entered, if FDA: (A) inspects the facility after the date of entry of this Decree and provides

written notice of the inspection findings, and (B) after reviewing Defendants’ response to those

findings (provided such response is received within fifteen (15) business days of receipt of the

inspection findings), determines that the inspection findings would result in an inspection

classification of Official Action Indicated (“OAI”). For any facility added as an Other SRC

Facility after (A) and (B) are met, if a subsequent inspection finds violations of the Act or its

implementing regulations, FDA may order Defendants to take any or all of the actions described

in paragraph 18.

23. Representatives of FDA shall be permitted, without prior notice and as and when

FDA deems necessary, to make inspections of Defendants’ Facilities and take any other

measures necessary to monitor and to ensure continuing compliance with the terms of this

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 38 of 73

Decree. During such inspections, FDA representatives shall be permitted to: access buildings,

equipment, in-process and finished materials, containers, and labeling therein; take photographs

and make video recordings; take samples of Defendants’ materials and products, containers, and

labeling; and examine and copy all records relating to the manufacture, holding, and distribution

of any and all Devices. The inspections shall be permitted upon presenting a copy of this Decree

and appropriate credentials. The inspection authority granted by this Decree is separate from,

and in addition to, the authority to make inspections under the Act, 21 U.S.C. § 374.

24. Defendants shall reimburse FDA for the costs of all FDA inspections,

investigations, supervision, reviews, examinations, and analyses that FDA deems necessary to

evaluate Defendants’ compliance with this Decree. The costs of such inspections shall be borne

by Defendants at the prevailing rates in effect at the time the costs are incurred. As of the date

that this Decree is signed by the parties, these rates are: $116.47 per hour and fraction thereof per

representative for inspection work; $139.61 per hour or fraction thereof per representative for

analytical or review work; $0.67 per mile for travel expenses by automobile; government rate or

the equivalent for travel by air or other means; and the published government per diem rate or

the equivalent for the areas in which the inspections are performed per-day, per-representative

for subsistence expenses, where necessary. In the event that the standard rates applicable to

FDA supervision of court-ordered compliance are modified, these rates shall be increased or

decreased without further order of the Court.

25. Within ten (10) days of the entry of this Decree, Defendants shall post a copy of

this Decree in the employee common areas at Defendants’ Facilities where employees are

located and on Defendants’ intranet website in such a manner to ensure that it will be viewed by

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 39 of 73

such employees. Defendants shall ensure that the Decree remains posted in its employee

common areas and on their intranet website for as long as the Decree remains in effect.

26. Within twenty (20) days after the entry of this Decree, Defendants shall provide a

copy of this Decree, by email (with affirmative acknowledgment of review and receipt), personal

service or certified mail (restricted delivery, return receipt requested), to their Associated Persons

with responsibility for the manufacture and/or distribution of Devices at Defendants’ Facilities.

Within twenty-five (25) days of the entry of this Decree, Defendants shall provide to FDA an

affidavit stating the fact and manner of compliance with this paragraph, identifying the names,

addresses, and positions of all persons or entities who have received a copy of this Decree

pursuant to this paragraph, and attaching copies of the executed certified mail return receipts or

email with affirmative acknowledgment of review and receipt.

27. In the event that Defendants become associated, at any time after the entry of this

Decree, with new Associated Persons, Defendants shall: (A) within ten (10) days of the

commencement of such association, provide a copy of this Decree to each such Associated

Persons by email (with affirmative acknowledgment of review and receipt), personal service or

certified mail (restricted delivery, return receipt requested); and (B) provide to FDA within thirty

(30) days after the end of each calendar quarter an affidavit stating the fact and manner of

compliance with this paragraph, identifying the names, addresses, and positions of all persons or

entities who received a copy of this Decree pursuant to this paragraph, and attaching copies of

the executed email or certified mail return receipts.

28. The obligations under this Decree of each Individual Defendant (or any Substitute

Individual Defendant, as defined below) shall apply only to the extent of the Individual

Defendant’s (or the Substitute Individual Defendant’s) authorities, responsibilities, and/or

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 40 of 73

conduct at Defendant Entities. If, and for so long as, an Individual Defendant or an employee of

a Defendant Entity ceases to be employed by or act on behalf of such Defendant Entity or any of

its subsidiaries, affiliates, and/or “doing business as” entities, then, provided that a Substitute

Individual Defendant is added to the Decree as described below, that Individual Defendant or

employee shall no longer be subject to the terms of the Decree and shall be liable only for such

Individual Defendant’s act(s) or failure(s) to act under this Decree prior to the time such

Individual Defendant ceased to be employed by or to act on behalf of the Defendant Entities. An

Individual Defendant shall notify FDA within twenty (20) days after said Defendant ceases to be

employed or otherwise act for all of the Defendant Entities (including any of subsidiaries,

affiliates, and/or “doing business as” entities). Within thirty (30) days of such separation,

Defendant Entities shall designate an individual with the equivalent position and responsibilities

to be substituted as an Individual Defendant (“Substitute Individual Defendant”) and notify FDA

of the identity, starting date, and nature of employment of the Substitute Individual Defendant.

After Defendant Entities notify FDA of an appropriate Substitute Individual Defendant, FDA

and Defendant Entities shall submit a joint stipulation to the Court identifying the Substitute

Individual Defendant and requesting that the Court effect the substitution by order. The

Substitute Individual Defendant added to this Decree shall be bound by the Decree in the same

manner as the Individual Defendants originally named in the Decree.

29. Defendants shall notify FDA in writing at least fifteen (15) days before any

change in ownership, character, or name of their businesses, such as dissolution, assignment, or

sale resulting in the emergence of a successor corporation(s), the creation or dissolution of

partnerships, subsidiaries, franchisees, affiliates, or “doing business as” entities, or any other

change in the corporate structure of the Defendant Entities, or in the sale or assignment of any

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 41 of 73

business assets, such as buildings, equipment, or inventory, that may affect compliance with this

Decree. Defendants shall provide a copy of this Decree to any potential successor or assignee at

least fifteen (15) days before any sale or assignment. Defendants shall furnish FDA with an

affidavit of compliance with this paragraph no later than ten (10) days prior to such assignment

or change in ownership.

30. All notifications, correspondence, and communications required to be sent to

FDA by the terms of this Decree shall be sent via electronic mail to the Program Division

Director, FDA, Office of Medical Device & Radiological Health, Division 1, One Montvale

Avenue, Fourth Floor, Stoneham, MA 02180 at [email protected]. All

submissions should reference the case name and civil action number.

31. If Defendants fail to comply with any of the provisions of this Decree, including

any time frame imposed by or pursuant to this Decree, then, on written notice of the United

States of America in this proceeding, Defendants shall pay to the United States Treasury the sum

of fifteen thousand dollars ($15,000) in liquidated damages for each day such violation

continues, an additional sum of fifteen thousand dollars ($15,000) in liquidated damages for each

violation of the Act, its implementing regulations, and/or this Decree, and an additional sum in

liquidated damages equal to twice the retail value of each shipment of Devices that are

adulterated, misbranded, or otherwise in violation of the Act, its implementing regulations,

and/or this Decree. The annual total amount of such liquidated damages shall not exceed twenty

million dollars ($20,000,000.00) in any calendar year. Defendants understand and agree that the

liquidated damages specified in this paragraph are not punitive in nature and that they do not in

any way limit the ability of the United States of America to seek, or the Court to impose, civil

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 42 of 73

and criminal contempt remedies based on conduct that may also form the basis for the payment

of liquidated damages.

32. Defendants may petition FDA in writing to extend any deadline or time frame

provided herein, and FDA may grant such extension without seeking leave of Court. However,

any such petitions shall not become effective or stay any deadlines or the imposition of any

payments under this Decree unless granted by FDA in writing.

33. Should the United States of America bring, and prevail in, a contempt action to

enforce the terms of this Decree, Defendants shall, in addition to other remedies, reimburse the

United States of America for its attorneys’ fees, investigational expenses, expert witness fees,

travel expenses incurred by attorneys and witnesses, and administrative court costs relating to

such contempt proceedings.

34. All decisions specified in this Decree shall be vested in the discretion of FDA and

shall be final. When contested by Defendants, FDA’s decisions under this Decree shall be

reviewed by the Court under the arbitrary and capricious standard set forth in 5 U.S.C.

§ 706(2)(A). Review shall be based exclusively on the written record before FDA at the time the

decision was made. No discovery shall be taken by either party.

35. This Decree resolves only those claims set forth in the Complaint. Defendants

specifically state and agree that entry of this Decree does not preclude (and no provision of this

Decree shall limit or impair the United States’ ability to pursue) any criminal charges; criminal

or civil penalties; civil or administrative monetary claims arising under the False Claims Act,

31 U.S.C. §§ 3729-3733, Civil Monetary Penalties Law, 42 U.S.C. § 1320a-7a, or Program

Fraud Civil Remedies Act, 31 U.S.C. §§ 3801-3812; common law claims; breach of contract

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 43 of 73

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 44 of 73

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 45 of 73

For Defendants

__________________

ROY JAKOBS

CEO, KONINKLIJKE PHILIPS N.V.

Individually

_________________________________

STEVEN B. C DE BACA

Chief Patient Safety & Quality Officer,

KONINKLIJKE PHILIPS N.V.

Individually

_________________________________

THOMAS FALLON

Head of Quality, Sleep and Respiratory Care,

PHILIPS RS NORTH AMERICA LLC

Individually

_________________________________

DANIEL LEONARD

Business Leader, Sleep and Respiratory Care

President & CEO,

PHILIPS RS NORTH AMERICA LLC and

RESPIRONICS CALIFORNIA LLC

Individually and on behalf of

PHILIPS RS NORTH AMERICA LLC and

RESPIRONICS CALIFORNIA LLC

_________________________________

JEFF DILULLO

President & CEO,

PHILIPS HOLDING USA INC.

Individually and on behalf of

PHILIPS HOLDING USA INC.

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 46 of 73

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 47 of 73

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 48 of 73

For Defendants

_________________________________

ROY JAKOBS

CEO, KONINKLIJKE PHILIPS N.V.

Individually

_________________________________

STEVEN B. C DE BACA

Chief Patient Safety & Quality Officer,

KONINKLIJKE PHILIPS N.V.

Individually

_________________________________

THOMAS FALLON

Head of Quality, Sleep and Respiratory Care,

PHILIPS RS NORTH AMERICA LLC

Individually

__________________________ ______

DANIEL LEONARD

Business Leader, Sleep and Respiratory Care

President & CEO,

PHILIPS RS NORTH AMERICA LLC and

RESPIRONICS CALIFORNIA LLC

Individually and on behalf of

PHILIPS RS NORTH AMERICA LLC and

RESPIRONICS CALIFORNIA LLC

_________________________________

JEFF DILULLO

President & CEO,

PHILIPS HOLDING USA INC.

Individually and on behalf of

PHILIPS HOLDING USA INC.

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 49 of 73

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 50 of 73

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 51 of 73

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 52 of 73

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 53 of 73

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 54 of 73

APPENDICES

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 55 of 73

Appendix 1: Other Sleep and Respiratory Care Facilities

Block 6 & 7, No. 129, 2nd Industrial Ave., Tang Xia Yong Village, Yan Luo Sub-district, Bao An District,

Shenzhen, Guangdong, 518105, CHINA

Coyol Free Zone And Business Park, Building B37, Coyol Alajuela, Costa Rica

Respironics Deutschland GmbH & Co. KG, Gewerbestr. 17 Herrsching Bavaria, DE 82211*

*This facility is an Other SRC Facility under this Decree, but it will be subject to the requirements in

paragraphs 14-16 only if it directly or indirectly introduces, delivers for introduction, or causes the

introduction or delivery for introduction, into interstate commerce a Device, other than a shipment to

another Covered Respironics Facility for the sole purpose of (1) performing a failure investigation or (2)

rework of non-conforming product that will be returned to Respironics Deutschland.

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 56 of 73

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 57 of 73

PC Direct;

K090539

MNS

Omnilab Direct;

K090539

MNS

ECG electrode

K991105

DRX

ECG wireset;

K040595

OLV; OLZ

Sleepware G3;

K040595

OLV; OLZ

Sleepware;

K040595

OLV; OLZ

Encore/Encore Pro Data Management System;

K010263

BTT; BZD

EncoreAnywhere;

K092818

MNS

Flow Sensor;

K963380

BZC

FloTrak CO2 Sensor

K963380

BZC

DirectView Data Management System;

K121623

MNT

Encore Anywhere;

K121623

MNT

Universal Battery Pack (UBP2);

K121623

MNT

OMNILAB DIRECT

K121623

MNT

H2 Heated Humidifier

K030090

BTT

Heated Humidifier - MR850

K073706

BTT

Masimo MS Series

K100428

DQA

Mouthpiece, Angled;

Exempt

BYP

Mouthpiece, Straight;

Exempt

BYP

Mouthpiece, Angled Disposable;

Exempt

BYP

Mouthpiece, Reusable

Exempt

BYP

Multiple - Invasive;

Exempt

CAE

Flex Trach Adaptor 15 cm, 22M/15F-15F;

Exempt

CAE

Flex Trach Adaptor 15 cm, 22M/15F-22F

Exempt

CAE

Opti Chamber Valved Holding Chamber

K962822

CAF

OptiChamber Diamond with Lite Touch mask

K110293

NVP

Passover Humidifier

K945782

BTT

Patient Circuits

Exempt

CAI

Performance Tubing 6’

K140424

BZE

Performance Tubing;

Exempt

BYX

Low Range Cabinet Flow Meter;

Exempt

BYX

Oxygen Manifold Kit

Exempt

BYX

PLM Sensor

K940014

BZQ

Pressure Valve

K963250

BZD

Pro-Flow and Pro-Flow Plus Cannula Sensors;

K982293

MNR

Pressure Transducer Airflow Sensor (PTAF);

K982293

MNR

PTAF 2, 3, Lite

K982293

MNR

Remote Alarm

K913423

CBK

REMstar Heated Humidifier;

K090243

BZD

Encore Pro 2 Data Management System;

K090243

BZD

Universal Battery Pack (UBP2)

K122769

BZD

Respironics Disposable Heated Wire Circuits;

K110398

BZE

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 58 of 73

Disposable Adult/Ped Heated Active Circuit;

K110398

BZE

Disposable Adult/Ped Heated Passive Circuit

K110398

BZE

Roll Stand, DreamStation 2;

Exempt

FOX

Roll Stand, DreamStation;

Exempt

FOX

Roll Stand, BiPAP A-series;

Exempt

FOX

Roll Stand, OmniLab Advanced +;

Exempt

FOX

Roll Stand, Trilogy Evo;

Exempt

FOX

Wheelchair Mount, Trilogy Evo;

Exempt

FOX

Mounting Bracket, Trilogy Evo ;

Exempt

FOX

Roll Stand, SPRS-2 (H-111 cm);

Exempt

FOX

Mount, EV300

Exempt

FOX

Sleepmapper;

Exempt

OUG

Payer Integration Software;

Exempt

OUG

Omnilab Conncect;

Exempt

OUG

AOM;

Exempt

OUG

Encore Basic;

Exempt

OUG

DreamStation Cellular Modem;

Exempt

OUG

DreamStation Wi-Fi Accessory;

Exempt

OUG

HL7 Interface Utility;

Exempt

OUG

DreamStation Link Module;

Exempt

OUG

PR1 Wired/Wireless Modems

Exempt

OUG

Sleepware G3 Event Detection Software

K142988

MNR; OLV;

OLZ

Snoring Microphone

K940015

MNR

Thermistor Cannula Style

K960851

BZQ

Trilogy Nurse Call Adaptor Cable

K083526

CBK

DirectView Data Management System;

K093416

CBK

Trilogy Nurse Call Adaptor Cable

K093416

CBK

Universal Battery Pack (UBP2);

K093905

CBK

Trilogy Nurse Call Adaptor Cable

K093905

CBK

Trilogy Nurse Call Adaptor Cable;

K181170

CBK

Dual Limb Active Exhalation Valve;

K181170

CBK

Nurse Call Adaptor Cable – Alarm Open/Closed;

K181170

CBK

Nurse Call Rj9 Adapter Cable Open;

K181170

CBK

12/24V Battery Cable w/terminals or adapter;

K181170

CBK

External Flow Sensor Assembly Adult/Pediatric;

K181170

CBK

External Flow Sensor Assembly Pediatric/Infant

K181170

CBK

Trilogy Nurse Call Adaptor Cable;

K181166

CBK; NOU

Dual Limb Active Exhalation Valve;

K181166

CBK; NOU

Nurse Call Adaptor Cable – Alarm Open/Closed;

K181166

CBK; NOU

Nurse Call Rj9 Adapter Cable Open;

K181166

CBK; NOU

12/24V Battery Cable w/terminals or adapter;

K181166

CBK; NOU

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 59 of 73

External Flow Sensor Assembly Adult/Pediatric;

K181166

CBK; NOU

External Flow Sensor Assembly Pediatric/Infant;

K181166

CBK; NOU

Universal Battery Pack (UBP2);

K113053

MNS

DirectView Data Management System;

K113053

MNS

ProChamber Valved Holding Chamber

K032809

CAF

CoughAssist

K002598

NHJ

CoughAssist;

K122111

BYI; NHJ

Simply Clear

K122111

BYI; NHJ

Cough Assist T70

K121955

NHJ

Esprit/V200 Ventilator with APRV Option

K110083

CBK

Everflo/Everflo Q/L4;

K061261

CAW

OPI and non-OPI;

K061261

CAW

EverFlo Quiet;

K061261

CAW

Transfill;

K061261

CAW

Ultrafill Quiet;

K061261

CAW

EverFlo;

K061261

CAW

Everflo Ultrafill

K061261

CAW

A40 Heated Humidifier;

K121623

MNT

SimplyGo POC;

K111885

CAW

SimplyFlo POC;

K111885

CAW

SimplyGo Mini POC

K111885

CAW

Trilogy 100 BT International;

K083526

CBK

Trilogy 100 Ventilator;

K083526

CBK

Garbin Ventilator BT;

K083526

CBK

Trilogy 100 Ventilator BT, U.S.;

K083526

CBK

Trilogy EC Ventilator;

K083526

CBK

Trilogy 200 Ventilator;

K093416

CBK

Trilogy 200 Ventilator BT;

K093416

CBK

Trilogy 200 Ventilator BT International;

K093416

CBK

Garbin Plus Ventilator;

K093416

CBK

Trilogy 202 Ventilator;

K093905

CBK

Trilogy Evo Universal Ventilator;

K181170

CBK

Trilogy Evo Ventilator;

K181166

CBK; NOU

Trilogy EV300

K181166

CBK; NOU

A30 Heated Humidifier;

K113053

MNS

V200 Ventilator

K102054

CBK

V200 Ventilator with Intelli-Trak Option

K110795

CBK

V60 Ventilator

K082660

MNT

V60 with PPV and Auto-Trak +

K102985

MNT

Assess Low Range Peak Flow Meter

K902292

BZH

Asthma Check;

K962925

BZH

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 60 of 73

Peak Flow Meter

K962926

BZH

Chest Shell and components

K895849

BYT

Heated Humidifier - HC100

K915460

BTT

Heated Humidifier - HC500

K953392

BTT

Heated Humidifier - MR410

K913367

BTT

Millenium M10;

K043006

CAW

OPI & non-OPI;

K043006

CAW

Millennium Transfill

K043006

CAW

NEV-100

K910947

BYT

Oasis Humidifier

K964653

BTT

Quantum Respiratory Effort Sensor

K913395

BZG

SmartSleep, Deep Sleep Headband

Exempt

HCC

Stardust 2;

Stardust I, II

K052573

MNR

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 61 of 73

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 62 of 73

CPAP VALVES

K950397

BYE

Crystal Trace Piezo Sensor

K923402

BZQ

Disposable 22mm non-heated passive and heated active circuits;

Exempt

BZO

Disposable 15 mm non-heated passive and heated active circuits;

Exempt

BZO

Disposable 15mm MPV circuit

Exempt

BZO

Disposable Adult/Ped Heated Active Circuit;

K110398

BZE

Disposable Heated Wire Circuits;

K110398

BZE

Disposable Adult/Ped Heated Passive Circuit

K110398

BZE

Drain, Tee (water trap)

Exempt

BYH

PC Direct;

K090539

MNS

Omnilab Direct;

K090539

MNS

DreamWear Full Mask;

K140980

BZD

DreamWear Nasal Mask;

K140980

BZD

DreamWear Gel Pillows Mask;

K140980

BZD

DreamWisp Nasal Mask

K140980

BZD

Dreamwear Silicone Pillows Mask

K210844

BZD

ECG electrode

K991105

DRX

ECG wireset;

K040595

OLV; OLZ

Sleepware G3;

K040595

OLV; OLZ

Sleepware;

K040595

OLV; OLZ

Encore/Encore Pro Data Management System;

K010263

BTT; BZD

EncoreAnywhere;

K092818

MNS

Flow Sensor;

K963380

BZC

FloTrak CO2 Sensor

K963380

BZC

DirectView Data Management System;

K121623

MNT

Encore Anywhere;

K121623

MNT

Universal Battery Pack (UBP2);

K121623

MNT

OMNILAB DIRECT

K121623

MNT

H2 Heated Humidifier

K030090

BTT

Headgear;

Chin Strap

Exempt

BTK

Heated Humidifier - MR850

K073706

BTT

Masimo MS Series

K100428

DQA

Mouthpiece, Angled;

Exempt

BYP

Mouthpiece, Straight;

Exempt

BYP

Mouthpiece, Angled Disposable;

Exempt

BYP

Mouthpiece, Reusable

Exempt

BYP

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 63 of 73

Multiple - Invasive;

Exempt

CAE

Flex Trach Adaptor 15 cm, 22M/15F-15F;

Exempt

CAE

Flex Trach Adaptor 15 cm, 22M/15F-22F

Exempt

CAE

Opti Chamber Valved Holding Chamber

K962822

CAF

OptiChamber Diamond with Lite Touch mask

K110293

NVP

Passover Humidifier

K945782

BTT

Patient Circuits

Exempt

CAI

Performance Tubing 6’

K140424

BZE

Performance Tubing;

Exempt

BYX

Low Range Cabinet Flow Meter;

Exempt

BYX

Oxygen Manifold Kit

Exempt

BYX

Performax FitLife SE Total Face Mask

K092648

CBK

PerforMax Pediatric EE Total FFM - Leak 1

K120562

BZD

PerforMax Pediatric EE Total FFM - Leak 2

K120562

BZD

Performax Pediatric SE Total FFM

K120639

CBK

Performax Youth Mask;

K092043

MNS

Performax, FitLife EE Total Face Mask

K091271

BZD

PLM Sensor

K940014

BZQ

PN841 SE Nasal Mask;

K151120

BZD

PN841 Nasal Mask;

K151120

BZD

Wisp Pediatric Nasal Mask SE Elbow Accessory;

K151120

BZD

Wisp Pediatric Nasal Mask

K151120

BZD

Pressure Valve

K963250

BZD

Pro-Flow and Pro-Flow Plus Cannula Sensors;

K982293

MNR

Pressure Transducer Airflow Sensor (PTAF);

K982293

MNR

PTAF 2, 3, Lite

K982293

MNR

Remote Alarm

K913423

CBK

REMstar Heated Humidifier;

K090243

BZD

Encore Pro 2 Data Management System;

K090243

BZD

Universal Battery Pack (UBP2)

K122769

BZD

Respironics Disposable Heated Wire Circuits;

K110398

BZE

Disposable Adult/Ped Heated Active Circuit;

K110398

BZE

Disposable Adult/Ped Heated Passive Circuit

K110398

BZE

Roll Stand, DreamStation 2;

Exempt

FOX

Roll Stand, DreamStation;

Exempt

FOX

Roll Stand, BiPAP A-series;

Exempt

FOX

Roll Stand, OmniLab Advanced +;

Exempt

FOX

Roll Stand, Trilogy Evo;

Exempt

FOX

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 64 of 73

Wheelchair Mount, Trilogy Evo;

Exempt

FOX

Mounting Bracket, Trilogy Evo ;

Exempt

FOX

Roll Stand, SPRS-2 (H-111 cm);

Exempt

FOX

Mount, EV300

Exempt

FOX

Sleepmapper;

Exempt

OUG

Payer Integration Software;

Exempt

OUG

Omnilab Conncect;

Exempt

OUG

Encore Basic;

Exempt

OUG

DreamStation Cellular Modem;

Exempt

OUG

DreamStation Wi-Fi Accessory;

Exempt

OUG

HL7 Interface Utility;

Exempt

OUG

DreamStation Link Module;

Exempt

OUG

PR1 Wired/Wireless Modems

Exempt

OUG

Sleepware G3 Event Detection Software

K142988

MNR; OLV;

OLZ

Snoring Microphone

K940015

MNR

Therapy Mask 3100 NC/SP

K210386

BZD

Thermistor Cannula Style

K960851

BZQ

Trilogy Nurse Call Adaptor Cable

K083526

CBK

DirectView Data Management System;

K093416

CBK

Trilogy Nurse Call Adaptor Cable

K093416

CBK

Universal Battery Pack (UBP2);

K093905

CBK

Trilogy Nurse Call Adaptor Cable

K093905

CBK

Trilogy Nurse Call Adaptor Cable;

K181170

CBK

Dual Limb Active Exhalation Valve;

K181170

CBK

Nurse Call Adaptor Cable – Alarm Open/Closed;

K181170

CBK

Nurse Call Rj9 Adapter Cable Open;

K181170

CBK

12/24V Battery Cable w/terminals or adapter;

K181170

CBK

External Flow Sensor Assembly Adult/Pediatric;

K181170

CBK

External Flow Sensor Assembly Pediatric/Infant

K181170

CBK

Trilogy Nurse Call Adaptor Cable;

K181166

CBK; NOU

Dual Limb Active Exhalation Valve;

K181166

CBK; NOU

Nurse Call Adaptor Cable – Alarm Open/Closed;

K181166

CBK; NOU

Nurse Call Rj9 Adapter Cable Open;

K181166

CBK; NOU

12/24V Battery Cable w/terminals or adapter;

K181166

CBK; NOU

External Flow Sensor Assembly Adult/Pediatric;

K181166

CBK; NOU

External Flow Sensor Assembly Pediatric/Infant;

K181166

CBK; NOU

Pico Nasal Mask / Pico SE Nasal Mask

K110405 &

K121631

BZD

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 65 of 73

Universal Battery Pack (UBP2);

K113053

MNS

DirectView Data Management System;

K113053

MNS

Whisper Swivel II;

Disposable Swivel Passive Exhalation Port

K962203

BZD

WhisperFlow Procedure Packs

K982283

BYE

Wisp Nasal Mask;

K121631

BZD

Wisp SE Nasal Mask

K121631

BZD

Wisp Youth Nasal Mask

K140268

BZD

Amara FFM / Amara Gel FFM

K082866

BZD

Comfort Gel Blue Nasal Mask

K092835

BZD

PTrak FFM

K002465

BZD

Nuance Pro Nasal Pillow Mask

K122847

BZD

Alice Nightone

K083874

MNR

Alice PDX

K090484

MNR

Bipap Focus

K053168

MNS

BiPAP Harmony 2 & S/T

K031656

MNS

BiPAP Plus M & Heated Humidifier;

Omnilab Direct

K061034

BZD

BiPAP Pro 2 & Heated Humidifier;

Or Components

K043607

BZD

BiPAP Q-Series w/HT;

K113068

BZD

REMstar/BiPAP Q-Series w/HT;

K113068

BZD

REMstar Q-series CPAP w/HT

K113068

BZD

BiPAP Q-Series;

K091319

BZD

REMstar Q-Series CPAP;

K091319

BZD

BiPAP Vision;

K982454

MNT

CoughAssist

K002598

NHJ

CoughAssist;

K122111

BYI; NHJ

Simply Clear

K122111

BYI; NHJ

Cough Assist T70

K121955

NHJ

Dreamstation 2 System;

K200480

BZE; BZD

Dreamstation 2 Advanced System

K200480

BZE; BZD

DreamStation BiPAP AVAPS w/ & w/o Humidifier;

K090539

MNS

BiPAP autoSV ADV w/Hum 30cm;

K090539

MNS

System One BiPAP w/ & w/o Humidifier

K090539

MNS

DreamStation BiPAP S/T w/ & w/o Humidifier;

K090539

MNS

DreamStation BiPAP autoSV w/ & w/o Humidifier;

K090539

MNS

Omnilab Advanced/Advanced +;

K090539

MNS

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 66 of 73

BiPAP autoSV Advanced;

K090539

MNS

System One CPAP w/ & w/o Humidifier

K090539

MNS

DreamStation CPAP w/ & w/o Humidifier;

K131982

BZD

DreamStation BiPAP Auto w/ & w/o Humidifier;

K131982

BZD

Dreamstation CPAP Pro w/ & w/o Humidifier;

K131982

BZD

Dreamstation CPAP Auto w/ & w/o Humidifier;

K131982

BZD

REMstar Auto A-flex HT (Q-series);

K131982

BZD

DreamStation BiPAP Pro w/ & w/o Humidifier;

K131982

BZD

DreamStation Go CPAP;

K131982

BZD

DreamStation Go Auto CPAP;

K131982

BZD

Dreamstation GO w/ & w/o Humidifier;

K131982

BZD

DreamStation CPAP Assist

K131982

BZD

Alice PSG or components;

K040595

OLV; OLZ

Alice 6 Headbox LDE;

K040595

OLV; OLZ

Alice 6 PSG Base Station LDE;

K040595

OLV; OLZ

REMstar Plus CPAP;

K010263

BTT; BZD

REMstar Heated Humidifier

K010263

BTT; BZD

BiPAP AVAPS or S/T C-Series;

K092818

MNS

BiPAP autoSV Advanced

K092818

MNS

Esprit/V200 Ventilator with APRV Option

K110083

CBK

Everflo/Everflo Q/L4;

K061261

CAW

OPI and non-OPI;

K061261

CAW

EverFlo Quiet;

K061261

CAW

Transfill;

K061261

CAW

Ultrafill Quiet;

K061261

CAW

EverFlo;

K061261

CAW

Everflo Ultrafill

K061261

CAW

A40 Heated Humidifier;

K121623

MNT

I-Neb AAD Nebulizer w/Insight SW or Components

K052941

CAF

I-neb TIM/General Purpose

K102454

CAF

Innospire Essence;

Innospire Elegance

K042655

BTI; CAF

REMstar Auto w/C-Flex & Heated Humidifier

K041010

BZD

REMstar Pro M-Series & Heated Humidifier

K072996

BZD

REMstar Pro w C Flex CPAP System

K021861

BZD

REMStar SE CPAP

K130077

BZD

REMstar SE CPAP;

K122769

BZD

Dorma CPAP;

K122769

BZD

SimplyGo POC;

K111885

CAW

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 67 of 73

SimplyFlo POC;

K111885

CAW

SimplyGo Mini POC

K111885

CAW

Trilogy 100 BT International;

K083526

CBK

Trilogy 100 Ventilator;

K083526

CBK

Garbin Ventilator BT;

K083526

CBK

Trilogy 100 Ventilator BT, U.S.;

K083526

CBK

Trilogy EC Ventilator;

K083526

CBK

Trilogy 200 Ventilator;

K093416

CBK

Trilogy 200 Ventilator BT;

K093416

CBK

Trilogy 200 Ventilator BT International;

K093416

CBK

Garbin Plus Ventilator;

K093416

CBK

Trilogy 202 Ventilator;

K093905

CBK

Trilogy Evo Universal Ventilator;

K181170

CBK

Trilogy Evo Ventilator;

K181166

CBK; NOU

Trilogy EV300

K181166

CBK; NOU

A30 Heated Humidifier;

K113053

MNS

V200 Ventilator

K102054

CBK

V200 Ventilator with Intelli-Trak Option

K110795

CBK

V60 Ventilator

K082660

MNT

V60 with PPV and Auto-Trak +

K102985

MNT

C serie CPAP / AVAPS and BiPAP S/T

K102465

MNS

LDx;

K040595

OLV; OLZ

LDxN;

K040595

OLV; OLZ

LDxS

K040595

OLV; OLZ

Digital Manometer

K904935

CAP

Innospire Mini

K060404

CAF

LifecarePressure Alarm Cat.No34-010

K894361

CAP

Lifeline Personal Response System;

Communicator, autoalert help button, mobile help button, personal

help button, handset

K914103

ILQ

LiquiCell CPAP Cushions

Exempt

FMP

LiteTouch Mask

K100285

CAF

Masimo Oximetry Kit

K111610

CBK; DQA;

NOU

Medication Dispenser

NXQ

Meter, Peak Flow, Spirometry

K912866

BZH

Personal Best EU Peak Flow Meter;

K912866

BZH

Personal Best Full Range Peak Flow Meter

K912866

BZH

Nonin Oximetry Kit

K111378

MNS

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 68 of 73

Oasis Humidifier

K964653

BTT

Personal Best Low Range Peak Flow Meter

K933889

BZH

PLV-102 & 102b

K842876

CBK

PLVC Continuum II

K034032

CBK; NOU

Sidestream Disposable Neb and Masks

K924123

CAF

Sidestream Plus Adult Mask;

K062689

CAF

Sidestream Plus Nebulizer;

K062689

CAF

Sidestream Plus Pediatric Mask

K062689

CAF

Sidestream Reusable Neb and Masks

K991725

CAF

Sidestream Tucker The Turtle Mask;

K940888

BYG

Spectrum;

Actiwatch Score

K983533

GWQ

System 22 Paediatric Mask

K940888

BYG

SleepEasy

K091112

BZD

Somnolyzer 24 x 7

K083620

MNR

Stardust 2;

Stardust I, II

K052573

MNR

System 22 Aerosol Mask

Exempt

BYG

Threshold IMT

K870514

BWF

Threshold Pep

K961077

BWF

REMstar M Auto w/A-Flex CPAP

K090243

BZD

CoughAssist

K002598

NHJ

CoughAssist;

K122111

BYI; NHJ

Simply Clear

K122111

BYI; NHJ

Cough Assist T70

K121955

NHJ

Esprit/V200 Ventilator with APRV Option

K110083

CBK

Everflo/Everflo Q/L4;

K061261

CAW

OPI and non-OPI;

K061261

CAW

EverFlo Quiet;

K061261

CAW

Transfill;

K061261

CAW

Ultrafill Quiet;

K061261

CAW

EverFlo;

K061261

CAW

Everflo Ultrafill

K061261

CAW

A40 Heated Humidifier;

K121623

MNT

SimplyGo POC;

K111885

CAW

SimplyFlo POC;

K111885

CAW

SimplyGo Mini POC

K111885

CAW

Trilogy 100 BT International;

K083526

CBK

Trilogy 100 Ventilator;

K083526

CBK

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 69 of 73

Garbin Ventilator BT;

K083526

CBK

Trilogy 100 Ventilator BT, U.S.;

K083526

CBK

Trilogy EC Ventilator;

K083526

CBK

Trilogy 200 Ventilator;

K093416

CBK

Trilogy 200 Ventilator BT;

K093416

CBK

Trilogy 200 Ventilator BT International;

K093416

CBK

Garbin Plus Ventilator;

K093416

CBK

Trilogy 202 Ventilator;

K093905

CBK

Trilogy Evo Universal Ventilator;

K181170

CBK

Trilogy Evo Ventilator;

K181166

CBK; NOU

Trilogy EV300

K181166

CBK; NOU

A30 Heated Humidifier;

K113053

MNS

V200 Ventilator

K102054

CBK

V200 Ventilator with Intelli-Trak Option

K110795

CBK

V60 Ventilator

K082660

MNT

V60 with PPV and Auto-Trak +

K102985

MNT

AF421 SE FFM

K101131

CBK

AF421 FFM

K101132

MNS

AF811 FFM

K073600

BZD

ComfortFull FFM

K082866

BZD

Assess Low Range Peak Flow Meter

K902292

BZH

Asthma Mentor

K962924

BZH

Asthma Check;

K962925

BZH

Peak Flow Meter

K962926

BZH

Chest Shell and components

K895849

BYT

Contour Deluxe/Comfort/Ptrak Nasal Mask;

K991648

BZD

AP111 EE/SE Nasal Mask

K991648

BZD

EasyLife Nasal Mask

K091843

BZD

GoLife Nasal Mask;

K121623

MNT

Heated Humidifier - HC100

K915460

BTT

Heated Humidifier - HC500

K953392

BTT

Heated Humidifier - MR410

K913367

BTT

LiteTouch Mask

K100285

CAF

Mask Cushion Adhesive (AF531)

Exempt

KGX

Millenium M10;

K043006

CAW

OPI & non-OPI;

K043006

CAW

Millennium Transfill

K043006

CAW

NEV-100

K910947

BYT

Nuance Nasal Pillow Mask

K122847

BZD

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 70 of 73

Oasis Humidifier

K964653

BTT

Quantum Respiratory Effort Sensor

K913395

BZG

SM Child Nasal Mask

K883825

BYE

SmartSleep, Deep Sleep Headband

Exempt

HCC

Stardust 2;

Stardust I, II

K052573

MNR

System 22 Aerosol Mask

Exempt

BYG

Total Face Mask

K992969

BZD

TrueBlue Nasal Mask;

K110405

BZD

Shimmer Full Face Mask

K142554

BZD

ComfortGel Blue FFM

K073600

BZD

ComfortGel Blue SE FFM;

K023135

CBK

ComfortClassic

K082558

BZD

Profile Lite

K082558

BZD

Comfort Lite

K082558

BZD

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 71 of 73

Appendix 4: Consumables, Accessories, and Replacement Parts

Consumables & Accessories:

1. Face Masks and Cannulas along with required Elbows, Headgears, Straps, sizing gauges and

Cushions

2. Active / Passive + Heated / Non-Heated Circuits and Tubes (22mm, 15mm, 12mm) and required

connectors, mounts and adaptors

3. Mouth Piece Ventilation circuit kit

4. Humidifiers, Humidification controls and chambers, water trap

5. Exhalation valves, ports, swivels and porting blocks

6. Oximetry kits including cables and power supplies

7. Bacteria filters, Foam/Air filters, Exhalation and Inspiratory filters and associated adapters and

connectors

8. Trach Adapter

9. O2 inlet adapter and other inlet airpath assemblies and hose

10. NIVO controller and kits

11. Volume Control Ventilation kits

12. Aerosol Delivery kits

13. Sidestream reusable and disposable nebulizer kits

14. Pressure Valve and O2 valves

15. Roll Stands, mounting kits, circuit support arms and hangers

16. Spacers and Holding chambers

17. Peak Flow meters

18. Foot Pedals

19. O2 Manifold/Transport kit and Cylinder holder/cart

20. Test lungs

21. Modems, Networking and data cards and readers

22. Sensors and monitoring kits for monitoring patients on therapy devices

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 72 of 73

23. Sensors, cables and software for continued use of Philips Respironics Diagnostic install base of

devices (capnography sensor, ProTech sensor, Software, microphones, video camera, Axis video

server, cables, mounts, headbox)

24. Leads, pads and Yoke for continued use of Philips Respironics Diagnostic install base of devices

25. Diaphragm kits

26. Nurse call alarm with associated cable and adapters

27. Remote alarm along with required cables, stand and power supplies

28. Communication Cables

29. Ventilation Displays

30. Mask fitting software

31. Data Management Software and accessories

32. Patient management and engagement Software

33. Field Installable Software maintenance and upgrades

34. Carrying cases and attachment straps

35. Training materials and instructions

36. Power Supplies including Batteries, AC Power modules, DC Power modules and associated

cables and chargers

Replacement parts:

All service parts as needed for service / repair of the install base of products including the following

examples:

37. PCBAs (printed circuit board assemblies)

38. Modem kits

39. Humidifier repair kits

40. Blower repair kits

41. Airpath repair kits

Case 2:24-cv-00505-RJC Document 16 Filed 04/09/24 Page 73 of 73