Phillips Respironics has issued a voluntary recall of around 4 million CPAP and BiLevel PAP devices. According to the manufacturer’s notification, the company’s quality management system revealed these products pose serious health risks and potentially life-threatening injuries for users.
The first-generation DreamStation product family comprises the Philips medical devices most affected by the recall.
Because the Instructions for Use failed to warn of the dangerous health risks associated with Philips’ CPAP, Bi-Level PAP, and mechanical ventilator devices, people who purchased the affected products prior to June 14, 2021, have filed a lawsuit against the manufacturer. The legal action (Manna v. Koninkelijke Philips N.V., et al.; Case No. 1:21-cv-11017) was filed on June 17, 2021. Individuals who used any of these Philips devices and developed cancer, lung or kidney damage or disease, or suffered a heart attack/failure may be eligible for compensation.
What’s Wrong With the Philips CPAP, Bi-Level PAP, and Mechanical Ventilator Devices
Philips’ voluntary recall of certain specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices stems from problems with their polyester-based polyurethane (PE-PUR) sound abatement foam component. According to Philips, the foam has been shown to disintegrate or outgas, releasing toxic and potentially carcinogenic substances that can enter into the devices’ air pathway where it can be ingested or inhaled by users.
Philips’ first-quarter 2021 report announced the adverse, foam-related effects of the medical devices. The maker also suggested that foam degradation could be prompted by unapproved cleaning methods, as well as high humidity and temperature. These conditions connect with environmental conditions in where the products are used and/or stored, not with how patients use the devices.
Health Risks of Using Philips’ CPAP devices
Numerous health risks have been identified as risks of using the affected Philips devices. The foam degradation poses risks from particulate exposure, including cancer; toxic effects; respiratory difficulties; damage to kidneys, liver, and other organs; inflammation; headache; and irritated eyes, skin, and respiratory tracts.
Several risks also present themselves from off-gassing when volatile organic compounds and chemicals are released in vapor form. These health risks include cancer; toxic effects; hypersensitivity; and nausea and vomiting.
Scope of the Recall
The Philips recall affects between three and four million devices that contain the sound abatement foam. The company has a 65 percent share of the CPAP market.
Among the customers is the United States Department of Veterans Affairs (VA). The agency distributed around 300,000 of these products to veterans for their use at home. An additional 2,000 devices were sent to VA clinics and hospitals.
CPAP users concerned about whether the devices they use are affected by this recall can complete an online form on the Philips website.
What to Do if You Were Affected by the CPAP and Bi-Level PAP Devices
Philips urges users of BiLevel PAP and CPAP devices to immediately cease their use and ask their doctors for alternative forms of treatment. Patients who use the affected life-sustaining ventilator devices should also discontinue their use until they had had the chance to speak with their doctors.