Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand)


Philips Sleep and Respiratory Care Devices – Australia and New Zealand

On Friday July 2 2021, following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, Philips Australia and New Zealand announced an Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand for specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.

Our teams have been and continue to work on a comprehensive correction program to support patients with an affected device. As a first step, if your device is affected, please start the registration process here.

As we continue to work through the correction, we assure you that we are fully committed to supporting all patients to complete correction efforts.

Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you.

Stop icon

Ozone and UV light cleaning products are not currently approved cleaning methods for sleep apnoea devices or masks and should not be used.

Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. Images may vary.

Not yet registered?

1800 009 579 in Australia or 0800 578 297 in New Zealand

Resources from Philips Respironics

Further information in relation to the global recall and devices has been made available by the legal manufacturer, Philips RS North America LLC (Philips Respironics), a company based in the USA.

The following updates in relation to device testing have been released by Philips Respironics on this webpage:

Please note that the Philips Respironics website also contains information specific to the CPAP, BiPAP and mechanical ventilator device recall in the USA, which may be different to and not relevant for Australia and New Zealand.

 

This information has not been separately verified by Philips Electronics Australia Ltd.

Resources from Royal Philips

Further information in relation to the global recall has been made available by Koninklijke Philips N.V. (Royal Philips), a company based in the Netherlands.

The following updates in relation to the global recall and recent media articles have been released by Royal Philips on the below webpages:

Please note that the Royal Philips website also contains information specific to the CPAP, BiPAP and mechanical ventilator device recall in the USA, which may be different to and not relevant for Australia and New Zealand.

This information has not been separately verified by Philips Electronics Australia Ltd.

Questions and answers

The following products listed are affected by the correction:

CPAP and BiLevel PAP Devices

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

(excluding Reworked CPAP and BiPAP Devices* with a label on the base showing Rev 15 or a higher number)

Bar code

*Reworked CPAP and BiPAP Devices are new devices which have been reworked with new silicone sound abatement foam and a new internal air pathway and blower. While these Reworked CPAP and BiPAP Devices have a manufacturing date prior to 26 April 2021, they have never been used and are not affected by the correction. All Reworked CPAP and BiPAP Devices have a label on the base showing REV (short for revision) 15 or a higher number (refer example label above).

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30 Emergency Use Authorization

E30

(Emergency Use Authorization)

Continuous Ventilator, Non-life Supporting

DreamStation ASV image

DreamStation ASV

Also known as ​DreamStation BiPAP autoSV​

DreamStation ST, AVAPS

DreamStation AVAPS

Also known as​ DreamStation BiPAP AVAPS, ​DreamStation BiPAP S/T

SystemOne ASV4

SystemOne ASV4 (50 and 60 Series)

Also known as​ System One BiPAP autoSV, ​System One BiPAP autoSV Advanced​

C Series ST, AVAPS

C Series S/T, AVAPS (50 and 60 Series)

Also known as​ System One BiPAP AVAPS (C-Series), ​System One BiPAP S/T (C-Series)​​​

OmniLab Advanced Plus(sleep lab) CPAP

OmniLab Advanced Plus

In-Lab Titration Device

Non-continuous Ventilator

50 Series CPAP, ASV

System One 50 series

CPAPs, Auto CPAP, BiPAPs​

60 Series CPAP, ASV

System One 60 series

CPAPs, Auto CPAP, BiPAPs​

DreamStation CPAP

DreamStation CPAP, Auto CPAP, BiPAP

DreamStation Go

DreamStation GO
CPAP, Auto CPAP

Mechanical Ventilators

All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers

Continuous Ventilator

Trilogy 100

Trilogy 100 Ventilator

Trilogy 200

Trilogy 200 Ventilator

Information for Trilogy 100 patients with a repaired device

 

There was an Alert issued to affected patients in November 2022, Product Defect Alert RC‐2022‐RN‐01396‐1. This Alert was related only to Trilogy 100 ventilators that were repaired. 

Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. 

If separation of the foam from the plastic backing was to occur, to the extent that therapy is impacted, your device will issue a High Priority alarm, either ‘Low Inspiratory Pressure’ or ‘Circuit Disconnect’. 

Previously we advised you to contact Philips Australia in the event of this alarm sounding, we would now like to update our instructions. If your ventilator is alarming with a High Priority alarm, you must do the following:

1. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilator’s operation. Always ensure you are being taken care of, i.e. That you are properly ventilated prior to referring to the instructions

IF THERE IS AN EMERGENCY, YOU MUST CALL 111

 

2. See ‘Ventilator Alarms’ on pages 2 – 4 of your Trilogy 100 Instructions for Use. Follow those instructions.

 

3. If you have a secondary back up device, switch over to that device.

 

4. Contact your clinical care team to determine if a loan device is required.

 

Philips Australia will work with your clinical care team to arrange a loan device, where required.

For more information click here
      

Continuous Ventilator, Non-life Supporting

A-Series BiPAP A40

A-Series BiPAP A40

Also known as ​BiPAP A40​ Ventilator ​(A-Series)​
(not marketed in US)​​

A-Series BiPAP A30

A-Series BiPAP A30

Also known as ​BiPAP A30​ Ventilator​ (A-Series)​
(not marketed in US)​​

What products are not affected and why?

 

Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.

  • Trilogy Evo

  • M-Series

  • Trilogy Evo OBM

  • Trilogy EV300

  • Trilogy 202

  • BiPAP A40 EFL

  • BiPAP A40 Pro

  • Omnilab (original based on Harmony 2)

  • All oxygen concentrators, respiratory drug delivery products, airway clearance products.

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