The Food and Drug Administration says 561 deaths have been reported in connection with recalled Philips devices to treat obstructive sleep apnea and other breathing disorders.
The FDA said that since April 2021, it has received more than 116,000 medical device reports of foam degradation in Philips CPAP (continuous positive airway pressure) machines and BiPAP sleep therapy devices. That includes 561 death reports, the agency said Wednesday.
The Dutch medical device maker has recalled millions of breathing devices because they were reported to blow gas and pieces of foam into the airways of those who used them.
Polyester-based polyurethane foam used in devices to reduce noise and vibration can break down and produce black pieces of foam or invisible chemicals that can be inhaled or swallowed by the person using the device. “These problems could potentially lead to serious injury and require medical intervention to prevent permanent injury,” the FDA said.
The grim tally comes days after Philips announced it would do so.in a settlement with the FDA and Department of Justice that is expected to cost about $400 million, the company disclosed in a regulatory filing.
The tentative agreement, which must be approved by a US court, calls for the company to continue servicing already-used apnea machines while stopping selling new ones until specific conditions are met.
After aTo repair or replace approximately 5.5 million fans worldwide, Philips then had to recall a limited number of fans after they were repaired, according to the company.
At the end of 2023, Philips acceptedusers of 20 different breathing devices and ventilators sold in the United States between 2008 and 2021. Claims for financial losses related to the purchase, rental, or rental of the recalled devices can now be filed following a project settlement of a class action concluded in September.
Claims for financial losses related to the purchase, rental or rental of the recalled devices may be filed, with eligible users entitled to:
- A Per-device payment pricing for each recalled device purchased, rented or leased;
- A Device Return Reward $100 for each recalled device returned before August 9, 2024; and or
- A Device replacement price for money spent to purchase a comparable device on or after June 14, 2021 and before September 7, 2023 to replace a recalled device.
How to file a claim
To determine if one is eligible and for instructions on what steps, if any, are required to receive a payment, the Settlement Administrator has set up an interactive website here.
Users can search the serial number of their recalled device to see which device payment reward they may be eligible for by clicking here.
Those who return a recalled Philips device before the August deadline are eligible for both return and payment rewards without having to submit a claim form and can use prepaid shipping labels for free by clicking here.
Those who spent their own money to purchase a CPAP or comparable replacement ventilator to replace a recalled device will need to complete a Device Replacement Request Form, which can be found here. A paper device replacement form can also be found here or by calling 1-855-912-3432.
The deadline for submitting claims is August 9, 2024.
The settlement does not impact or release any claims for personal injury or relief from medical supervision, according to the Administrator of the U.S. District Court for the Western District of Pennsylvania.
About 30 million people have sleep apnea, a disorder in which the airways become blocked while resting, stopping breathing, according to 2022 data from the American Medical Association.
The company has investigated all complaints and allegations of malfunction and serious injury resulting in death, and “found no vsconclusive data linking these devices and reported deaths, Philips told CBS MoneyWatch on Thursday.
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