Recall of Philips Sleep Apnoea Machine

In April 2021 Philips Respironics recalled from the worldwide market some of their ventilation machines used by patients for sleep apnoea and breathing difficulties.     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, often to vulnerable patients including children.

The problem stems from a type of foam (polyester-based polyurethane foam) used in the affected devices to reduce sound and vibration. The first identified issue is that the foam may degrade or break down 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 or release certain chemicals during use of the device.

The manufacturer has identified a number of potential risks, including headache, upper airway irritation, cough, chest pressure and sinus infection and potential risks related to exposure to carcinogens.

The advice from the HSE at the time was to “Keep using your device until you can get it replaced or repaired, or your doctor prescribes another treatment” see link to the advice in full https://www.hse.ie/eng/services/news/newsfeatures/advice-philips-respironics-devices/ and https://www.olchc.ie/children-family/philips-recall-field-safety-notice/

Cantillons have had a number of enquiries from patients affected and we continue our investigations with a view to achieving adequate compensation for any injuries users of these devices may have suffered.

The EU legislation providing safeguards for medical devices is occurring slowly but surely, since the launch of the EU Medical Devices Regulation (MDR) in 2017 which took effect in May 2021 with a transition period until May 2024. This global recall is a reminder that that overhaul is necessary and overdue to protect patients using medical devices.

Contact us at Cantillons Solicitors at Cork  +353 (0)21 4275673 or Dublin +353 (0)1 264 1802 or email info@cantillons.com  if you would like more information.

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Orla Kelly

Partner

Experience

Orla qualified as a Solicitor in 2014, having complete her traineeship with the firm. Since joining the firm in 2012, Orla has gained a variety of experience acting for clients and their families.Orla has a particular focus on medical negligence and defective medical device claims, including acting for clients who have received the recalled DePuy ASR hip device. Orla is also a Registered Pharmacist and previously worked for a number of years as a hospital clinical pharmacist. Her combined knowledge of pharmacy and law benefits her work in the Medical Negligence team at the firm.  She listens and responds to individual clients’ varying needs.

Qualifications / Associations

• Honours Bachelor’s Degree in Civil Law
• Honours Master’s Degree in Pharmacy
• Postgraduate Diploma in Clinical Pharmacy
• Admitted to the Roll of Solicitors 2014
• Member of Pharmaceutical Society of Ireland
• Member of Action Against Medical Accidents