Philips Respironics issued a medical device Field Safety Notice (FSN) on the 26th April 2021 for various machines used to care for sleep apnoea and respiratory difficulties. The Field Safety Notice can be read in full here and the statement from the HPRA can be accessed here.
The list of machines affected is here.
Also known as CPAP or BiPAP machines and Respirators, these devices are usually used by patients for sleep and respiratory care at home, in hospitals and in health care facilities.
There are concerns that the polyester based polyurethane sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and enter the device’s air pathway. If this occurs, black debris or chemicals may be inhaled or swallowed by the device user. The HSE has advised that this can cause irritation in the device user’s airway as well as cough, headache and sinus infection. The HSE has also indicated that the short term and long term effects on health are unknown but that some of the chemicals have the potential to cause cancer. The HSE is currently working with the Health Products Regulatory Authority (HPRA) and hospitals to assess the concerns and any potential issues for patients in Ireland.
All patients who are concerned should take the following steps: –
- Speak with your treating doctor to discuss your concerns.
- Identify if your device is a model impacted by the field safety notice. The list of affected devices can be found with the field safety notice here.
- Record the serial number of your device and register the details with the manufacturer. This can be done on their website by clicking here.
- Report any symptoms or adverse incidents associated with the device to both the manufacturer and the HPRA.
*Before acting or refraining from acting on anything in this guide, legal advice should be sought from a solicitor.
**In contentious cases, a solicitor may not charge fees as a percentage or proportion of any award or settlement.