A Field Safety Notice was issued by Philips Respironics on the 26 April 2021 for a number of their machines associated with treatement of sleep apnoea and other respiratory problems. The notice alerted people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.
The HPRA has published a notice confirming that the manufacturer has identified a number of potential risks, which may have significant effects on the users of these devices in the long term, including potential risks related to exposure to carcinogens. Globally, Philips has received several complaints to date regarding the presence of black debris/particles within the air pathway circuit (extending from the device outlet, humidifier, tubing, and mask). Philips has also received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.
The HSE have issued advice on their website which can be considered by users of the recalled machines. The HSE has asvised that they are working with the Health Products Regulatory Authority (HPRA) and their own hospital and community services to assess the issue and the potential impact on patients in Ireland. They are likely to continue to review their advice as Philips Respironics provides more information.
If you are a use of one of the affected machines (the list can be found here and here) you should:
- Consult with your doctor
- Take a note of the serial number of the machine
- fill out a
- Register the device on the Philips Website
- Report any health issues on the HPRA Website
- Preserve the machine for inspection to ascertain if the foam has degraded into particles which could go on to be inhaled or ingested by the user, and to see if the foam could have emitted certain chemicals during use of the device.
If you have been affected by any of these issues you can seek the assistance of your Solicitor. Contact Ronan Kennedy at ronankennedy@kfos.ie for more information.
