Philips Urgent Product Defect Correction
On June 14th 2021 Philips announced a US recall of their CPAP devices manufactured before 26th April 2021. This includes all CPAP devices sold by Philips in Australia, both current devices (DreamStation) and older devices (SystemOne – 50 and 60 series).
In Australia an ‘Urgent Product Defect Correction’ has been commenced by Philips in conjunction with the Therapeutics Goods Administration (TGA). As part of this process anyone with an affected device should:
- Register their device via this link
- Contact their physician or care provider for specific advice based on their situation
If you are a patient of the practice and use one of these devices don’t stop using your device unless you have noticed black particles coming from the machine or had symptoms. Please contact us to discuss options via:
- Email: reception@drdavidcunnington.com.au
- Phone: 03 8609 0308
Affected CPAP devices:
Links:
- Statement from Australasian Sleep Association
- Statement from Therapeutic Goods Administration (TGA)
- Product defect notice from TGA
- Details on product defect correction from Philips
- Technical information on product defect from Philips
- Register affected device for repair / replacement
- Philips call centre: 1800 009 579
What is the issue?
A detailed technical statement from Philips is available here.
Affected CPAP machines have been fitted with sound abatement foam that can degrade particularly in the context of heat, high humidity or if cleaned using ozone-based cleaners. This can lead to:
- Particulate matter being released. A small number of people have reported small black particles in the airflow outlet or CPAP tubing. These particles can be inhaled and cause symptoms such as cough, wheeze, shortness of breath, sinus infection and headache.
- Exposure due to chemical emissions from affected foam which can result in: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects
The potential risks can occur even if particulate matter hasn’t been seen or if people don’t have symptoms, so anyone with an affected device (above) should register their device with Philips so that it can be repaired or replaced and contact their sleep physician to discuss ongoing treatment options.
Philips have also recommended:
- Use of bacterial filters to reduce chance of particulate matter being inhaled from CPAP devices. (Note – although this is recommended these are in short supply and not likely to be available in sufficient quantity for everyone to use. Philips have also not provided information on where to purchase these or who will pay for them.)
- Stop use of ozone-based cleaners for CPAP and ensure device, tubing and mask are cleaned as per manufacturer’s instructions.
Updates
07.12.21: Information on replacing DreamStation
Philips have begun shipping replacement DreamStation devices to patients who have registered their existing devices for replacement. Philips aim to replace all registered DreamStations by end of January 2022.
08.10.21: Information on replacement and prioritisaion
Philips have released detailed information for clinicians on how to prioritise patients for urgent replacement of devices and a general outline of the plan to replace devices starting in October 2021.
09.07.21: Additional technical information released
Philips have released more detailed information on the actual issue with the sound abatement foam and associated risks. There have also been reports of people trying to remove the foam themselves with online videos showing how to do this. The TGA has advised against this.
02.07.21: Product defect correction notice issued
- Philips information on urgent product defect correction
- Link to register affected devices
- Philips call centre: 1800 009 579
Philips and the TGA have issued an Urgent Product Defect Correction and released details of how to register to have devices repaired or replaced. Advice to people with affected devices has been changed from telling people to stop treatment to advising people to contact their physician or care provider to discuss ongoing treatment.
29.06.21: Updated information
It is anticipated that a risk assessment from the TGA and details of replacement program for affected devices will be provided late this week or early next week. It appears that there is greater risk associated with use of ozone cleaners for CPAP. People should clean their CPAP equipment as per manufacturers’ instructions.
25.06.21: Updated Australian information
Whilst awaiting a full risk assessment from the Therapeutic Goods Administration (TGA), the Australasian Sleep Association recommend that people using the affected devices contact their sleep physician to discuss whether any changes should be made to their treatment.
22.06.21: Statements from International professional societies
In Australia we are awaiting details of a formal recommendations from the Therapeutic Goods Administration (TGA). The Australasian Sleep Association is formulating a statement whilst we await a formal recommendation from the TGA.
14.06.21: Recall announced in United States
There is not specific information for Australian patients or physicians. Discussions are ongoing between Philips and the TGA. It is anticipated that recall details will be outlined week of June 21st.
