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Advisory - Update on Philips Respironics recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators

·9 min read

OTTAWA, ON, July 27, 2022 /CNW/ -

Summary

  • Products: Philips Respironics Continuous Positive Airway Pressure (CPAP) machines, BiLevel Positive Airway Pressure (BiLevel PAP) machines and mechanical ventilators

  • Issue: Medical Devices – Quality issue

  • What to do:

Issue
UPDATE (2022-07-27): Update on Philips Respironics recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators

Health Canada is providing an update on the progress of Philips Respironics' (Philips) recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators in Canada. Since communicating about the recall in July 2021 (see below), Health Canada has been receiving questions from individuals who rely on these devices. The Department wants to reassure patients and their families that their health and well-being is a priority. The Department is closely monitoring the company's progress in resolving the safety issue and implementing a repair and replacement program for affected devices in Canada. Health Canada's safety recommendations have not changed from its July 2021 advisory.

Progress on remediation plan to date:
Philips has confirmed that it is repairing or replacing all devices affected by this recall, irrespective of the age of the device. Philips may replace devices with the same model, or a different Philips device that will meet the needs of the patient. Philips has advised Health Canada that it expects to complete its repair and replacement program in Canada by the end of 2023.

As part of the company's remediation plan, Philips will submit licence amendments for any proposed device design or material changes to address the foam degradation and off-gassing issues. The submissions must provide evidence that the safety concern has been addressed and that the changes are safe. While Health Canada cannot compel a company to submit a licence amendment, or to submit it within a certain timeline, the Department is prioritizing and expediting the review of each of these amendment packages when it receives them. To date, Health Canada has authorized licence amendments for all DreamStation CPAP and Bi-level Therapy devices (other than DreamStation Go devices).

Philips has yet to submit packages to Health Canada for A-Series, DreamStation Go, OmniLab, and Trilogy devices.

Once a licence amendment is authorized by Health Canada, Philips has indicated that it may take up to a year for that product to be repaired or replaced.

Importance of working with Durable Medical Equipment Providers
If you are a user of a recalled device, or you are unsure, please see the section below on What you should do. It is important that those affected by the recall register their device with Philips if they have not done so already. Users can register on the Philips recall website or by calling 1-877-907-7508. Philips has informed Health Canada that it is working through its Canadian network of medical device providers, known as Durable Medical Equipment Providers (DMEs), to coordinate device repairs and replacements. Users who do not currently have a DME can connect with one through Philips if they have registered their device with the company.

Device supply in Canada
This recall is global and affects millions of devices. The volume of recalled devices has put a strain on the worldwide supply of Philips devices and of alternatives. To help increase the availability of alternative options in Canada, Health Canada has fast-tracked its review of submissions from companies other than Philips to add devices to the List of medical devices for exceptional importation and sale. This list enables Health Canada to respond to device shortages by allowing the exceptional, temporary importation and sale of comparable medical devices not authorized for sale in Canada, but approved by other trusted regulators. To date, the following devices have been added to the list:

  •  

Health Canada is in regular communication with Philips to monitor this recall and to ensure that timely updates on replacement and repair are provided to the Department and to device users in Canada.

At Health Canada's request, the company will update its Canadian website to provide more information to Canadians affected by this recall.

Original Advisory (2021-07-30): Philips Respironics recalls several models of CPAP and BiLevel PAP machines and mechanical ventilators

Philips Respironics (Philips) has recalled several models of its Continuous Positive Airway Pressure (CPAP) machines, BiLevel Positive Airway Pressure (BiLevel PAP) machines and mechanical ventilators in Canada and internationally. The devices include a foam component that reduces sounds from the device. This foam may degrade (break down) into particles which may be inhaled or swallowed by users, or release volatile organic compounds (VOCs) that may be inhaled, which could lead to negative health effects.

Preliminary laboratory analysis by Philips determined that extreme operating temperatures and ozone cleaning methods may increase the breakdown of the foam. The company recommends against product use in temperatures outside of the labelled operating conditions, and the use of non-validated cleaning methods, such as ozone.

Philips has issued letters to customers, patients, and distributors with instructions for the recall. Philips indicates it will replace the foam component with a material that is not affected by this issue, or it will replace affected devices altogether.

Philips reports that they have received a relatively low number of complaints, some of which relate to black debris in the device air path, including the tubing and mask. Some users have reported headache, upper airway irritation, cough, chest pressure, and sinus infection, but it is has not yet been determined if degraded foam particles or VOCs were the cause.

Health Canada considers the benefits of using the affected devices to outweigh the risks for many users, and recommends that users not stop or alter their prescribed therapy before having a discussion with their health care professional.

For ventilators only, Health Canada cautions the use of in-line bacterial filters to mitigate foam particles, as they will not protect against VOC emissions and airflow can be negatively affected if the filter becomes clogged with debris.

What you should do

  • Register your device on the Philips recall website or call its recall hotline at 1-877-907-7508. Philips has established a registration process where you can look up your device serial number and begin a claim if your unit is affected.

  • If you have an affected product talk to your physician, or medical device provider first before stopping or changing how you use your product, as the benefits of using these devices may outweigh the risks for many users.

  • Be sure to clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods (e.g. ozone) could contribute to potential foam degradation.

  • Do not attempt to remove or replace the foam yourself.

  • Report any health product-related side effects or complaints to Health Canada.

What Health Canada is doing?
Health Canada is monitoring the recall and the availability of devices in Canada. The Department continues to work with the manufacturer to further assess potential health risks, any future design or material changes that may be proposed, and the appropriateness of the company's corrective actions.

The Department is also working with Philips to identify strategies to address any device shortages. If additional products or safety concerns are identified, Health Canada will take appropriate action and inform Canadians.

Affected products
The recall affects several models manufactured before April 26, 2021. Device photos are available on the company's recall website.

Product

Model or catalog number

BIPAP A30 SYSTEM-VENTILATOR

1076577

1111147

BIPAP A30 SYSTEM-VENTILATOR & SYSTEM ONE A-SERIES HEATED HUMIDIFIER

1076578

1111148

BIPAP A40, CANADA

1076579

1111173

BIPAP A40, CANADA, CORE PACKAGE

1111174

BIPAP AUTO BI-FLEX, WITH HUMIDIFIER, WITH SMARTCARD, CANADA

CA751HS

CA761HBT

CA761HS

CA761NTS

CA761TBT

CA761TS

BIPAP AUTO BI-FLEX, WITH SMARTCARD, CANADA

CA751S

CA761BT

CA761S

BIPAP AUTOSV ADVANCED SYSTEM ONE

CA951HS

CA951S

CA961HS

CA961NTS

CA961S

CA961TS

CA961XHS

CA961XS

CA961XTS

BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD

1044288

BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD/HEATED HUMIDIFIER

1044289

BIPAP AUTOSV WITH SMARTCARD INT

1044114

BIPAP AUTOSV WITH SMARTCARD INT, CORE PKG

1044235

BIPAP AVAPS CORE PACKAGE, NORTH AMERICA

1029750

BIPAP AVAPS VENTILATORY SUPPORT SYSTEM-CANADA

CA1060486

CA1161X

CAX1130S12

BIPAP AVAPS VENTILATORY SUPPORT SYSTEM-CORE PKG, CANADA

CA1061419

CA1161XTS

CAX1130H12

CAX1130H12C

CAX1130H12W

CAX1130T12

CAX1130T12C

BIPAP AVAPS, C SERIES VENTILAROTY SUPPORT SYSTEM-CORE PKG, DOMESTIC

1061418

BIPAP AVAPS, C SERIES VENTILATORY SUPPORT SYSTEM-DOMESTIC

1060485

BIPAP PRO BI-FLEX, WITH HUMIDIFIER, WITH SMARTCARD, CANADA

CA651HS

CA661HBT

CA661HS

CA661NTS

CA661TBT

CA661TS

BIPAP PRO BI-FLEX, WITH SMARTCARD, CANADA

CA651S

CA661S

BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM, CORE PKG, CANADA

CA1061423

BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM-CANADA

CA1061421

BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM-CORE PKG, DOMESTIC

1061422

BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH SMARTCARD

1029756

CA1029756

BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH SMARTCARD-CORE PACK

CA1029759

DREAMSTATION BIPAP PRO

CAX600H12

CAX600H12C

CAX600H12W

CAX600S12

CAX600T12

CAX600T12C

DREAMSTATION AUTO BIPAP

CAX700H12

CAX700H12C

CAX700H12W

CAX700S12

CAX700T12

CAX700T12C

CAX700T12W

DREAMSTATION AUTO CPAP

CAX500H12

CAX500H12C

CAX500H12W

CAX500S12

CAX500T12

CAX500T12C

CAX500T12W

DREAMSTATION BIPAP AUTO SV W/HUMID/HEATED TUBE, CA

CAX900T12

CAX900T12C

DREAMSTATION BIPAP AUTOSV, CA

CAX900S12

DREAMSTATION BIPAP AUTOSV, W/HUMIDIFIER, CA

CAX900H12

DREAMSTATION CPAP

CAX200H12

CAX200S12C

CAX200T12

DREAMSTATION CPAP PRO

CAX400H12

CAX400H12C

CAX400H12W

CAX400S12

CAX400T12

CAX400T12C

CAX400T12W

DREAMSTATION EXPERT

CAX501H12

CAX501H12C

CAX501T12

CAX5O1T12C

CAX5O1T12W

DREAMSTATION GO AUTO CPAP

CAG500S12

DREAMSTATION GO AUTO CPAP WITH HUMIDIFIER, CANADA

CAG500H12

DREAMSTATION GO CPAP

CAG400S12

DREAMSTATION GO CPAP WITH HUMIDIFIER, CANADA

CAG400H12

OMNILAB ADVANCED, DOMESTIC

1111122

OMNILAB ADVANCED, DOMESTIC CORE

1111123

1111124

REMSTAR AUTO WITH HUMIDIFIER, WITH SD CARD, A-FLEX, CANADA

CA551HS

CA561HBT

CA561HS

CA561NTBT

CA561NTS

CA561TBT

CA561TS

REMSTAR AUTO WITH SD CARD, A-FLEX, CANADA

CA551S

CA561BT

CA561S

REMSTAR PLUS WITH HUMIDIFIER, WITH SD CARD, C-FLEX, CANADA

CA251HS

CA261HS

CA261NTS

CA261TS

REMSTAR PLUS WITH SD CARD, C-FLEX, CANADA

CA251S

CA261S

REMSTAR PRO WITH HUMIDIFIER, WITH SD CARD, C-FLEX +, CANADA

CA451HS

CA461HBT

CA461HS

CA461NTBT

CA461NTS

CA461TBT

CA461TS

REMSTAR PRO WITH SD CARD, C-FLEX +, CANADA

CA451S

CA461BT

CA461S

REMSTAR, WITH SMARTCARD, CANADA

CA151S

REMSTAR, WITH HUMIDIFIER, WITH SMARTCARD, CANADA

CA151HS

TRILOGY 100 VENTILATOR, CANADA

CA1054096

CA1054096B

U1054260

TRILOGY 100 VENTILATOR-INTERNATIONAL

1054096

U1054096

TRILOGY 200, CANADA

CA1032800

CA1032800B

Related links

Également disponible en français

SOURCE Health Canada

Cision
Cision

View original content: http://www.newswire.ca/en/releases/archive/July2022/27/c4435.html