On Aug. 16, 2022 the U.S. Food and Drug Administration (FDA) issued an update on a June 2021 recall of certain ventilators, BiPAP (Bi-level Positive Airway Pressure), and CPAP (Continuous Positive Airway Pressure) breathing machines manufactured by Philips Respironics because of “potential health risks.”1 A list of the recalled devices made between 2009 and April 26, 2021 can be found here.
Polyester-based Polyurethane Can Degrade, Cause Injury
Philips Respironics recalled the devices because the polyester-based polyurethane (PE-PUR) sound abatement foam used to reduce sound and vibration could degrade. If this were to happen, black debris from the foam or certain invisible chemicals could be released into the device’s air pathway and inhaled or swallowed by the person using it.2 This could potentially end in in serious injury and require medical intervention to prevent permanent injury.3
The potential risks of inhaling or swallowing pieces of PE-PUR foam include irritation to the skin, eyes, nose and respiratory tract (airway), inflammation, headache, asthma and cancer-causing risks affecting organs such as kidneys and liver.4
The potential risks of inhaling chemicals released into the device’s air tubes from the PE-PUR foam include headache, dizziness, irritation in the eyes, nose, respiratory tract and skin, allergic reactions and another immune system reactions, nausea or vomiting, and cancer-causing effects.5
FDA Received 69,000 Complaints and 164 Death Reports Potentially Linked to Recalled Philips Breathing Devices
Following the FDA’s announcement in June 2021 recalling the affected Philips breathing devices, the agency received more than 69,000 complaints linked to the recall. Between April 2021 and April 2022, the FDA received 21,000 complaints and more than 120 reported deaths potentially related to the affected devices.6
Between May 1, 2022 and July 31, 2022, the FDA received many more medical device reports (MDRs)— over 48,000—involving Philips respiratory products, including 44 reports of death. MDRs include mandatory and voluntary reports of safety issues, injuries and deaths from patients, consumers and healthcare providers.7
France Launches Criminal Investigation into Philips Respiratory Devices Recall
France’s National Medicines Agency has received nearly 3,000 reports of adverse effects linked to Philips recalled ventilators and breathing machines. A criminal investigation into the company’s recall began on June 20, 2022. A spokesperson for the French prosecutors stated:
complaints filed on the grounds of aggravated deception, involuntary attacks on physical integrity, endangerment of the life of others and administration of harmful substances.8
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Click here to view References:
1 U.S. Food and Drug Administration. Update: Certain Phiips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Aug. 16, 2022.
3 FDA. Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Aug. 16, 2022.
6 Park A. One year into Philips’ ventilator foam recall, FDA tallies 124 deaths, 21,000 complaints. Fierce Biotech May. 23, 2022.
7 Park A. Philips recall sparks 48K complaints to FDA in 3 months, including 44 deaths. Fierce Biotech Aug. 17, 2022.
8 Park A. French prosecutors launch criminal investigation into Philips ventilator recall. Fierce Biotech Sept. 8, 2022.