Philips Sleep and Respiratory Care Devices

Last Updated: 19 July 2021

Background

As part of a global action, the manufacturer Philips Respironics has issued a Field Safety Notice in Ireland advising of two issues related to a number of different devices in the area of sleep and respiratory care. These devices may be used by patients either at home or in healthcare institutions such as hospitals or long-term care facilities and may be used to provide either continuous or non-continuous breathing support.

The devices affected by these issues are listed on the Philips Field safety notices available here and here, and the accompanying Safety Notice issued by the HPRA here.

Issues

The issues identified by Philips relate to the sound abatement foam, which is a component of the affected devices. The first identified issue is that the foam may degrade into particles which could go on to be inhaled or ingested by the user of the device and the second issue is that the foam may emit certain chemicals during use of the device.

As described in the field safety notices linked above, 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.

Information for users of these devices

It is important to identify if your device is one of the devices identified by the manufactured as affected by the issues above. In order to do this you should look at the list of devices on the field safety notices (here and here). If your device is listed as one of the affected device types, please see the advice published by the Health Service Executive (HSE) on their website

In addition, users are being asked by the manufacturer, Philips, to register their devices online or if you cannot visit the website or don’t have internet access you can register over the phone by dialling 1800 851 241.

Users who have experienced any issues with this medical device are encouraged to submit a report to the HPRA. Reports can be submitted via our online reporting form.

Information for healthcare professionals

Philips have published further information for healthcare professionals on its website. The HSE also has a dedicated webpage available with up to date information on the above issues.

In addition, healthcare professionals are asked to report any adverse incidence associated with these devices to the manufacturer and the HPRA.

Additional Information

The HPRA understands that the manufacturer Löwenstein Medical has issued a similar notification for Somnia 3 (i) and Phoenix 3(i) CPAP devices.  The manufacturer has confirmed affected devices have not been placed on the Irish market. The Löwenstein Medical Field Safety Notice is available here.