Current:Home > ContactFDA says 561 deaths tied to recalled Philips sleep apnea machines -FundPrime
FDA says 561 deaths tied to recalled Philips sleep apnea machines
View
Date:2025-04-12 18:31:34
The Food and Drug Administration says 561 deaths have been reported in connection to 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 breaking down in Philips CPAP (continuous positive airway pressure) machines and BiPAP sleep therapy devices. That includes 561 reports of death, the agency said Wednesday.
The Dutch medical device maker has recalled millions of the breathing machines amid reports they were blowing gas and pieces of foam into the airways of those using the devices.
The grim tally comes days after Philips said it would stop selling the machines in the U.S. in a settlement with the FDA and the Justice Department expected to cost roughly $400 million, the company disclosed in a regulatory filing.
The tentative agreement, which must be approved by a U.S. court, calls for the company to keep servicing apnea machines already being used while stopping to sell new ones until specific conditions are met.
After an initial recall announced in June of 2021, Philips attempted to fix some of the more than 5 million recalled devices, but the repaired ones were ultimately recalled as well.
Philips in late 2023 agreed to pay at least $479 million to compensate users of 20 different breathing devices and ventilators sold in the U.S. between 2008 and 2021. Claims for financial losses related to the purchase, lease or rent of the recalled machines can be now be lodged in the wake of a proposed class-action settlement reached in September.
Claims for financial losses related to the purchase, lease or rent of the recalled devices can be made, with eligible users entitled to:
- a Device Payment Award for each recalled device purchased, leased or rented;
- a Device Return Award of $100 for each recalled device returned by Aug. 9, 2024; and/or
- a Device Replacement Award for money spent to buy a comparable machine on or after June 14, 2021 and before Sept. 7, 2023 to replace a recalled device.
How to file a claim
To determine whether one is eligible and for instructions on what steps, if any, are needed to receive a payment, the settlement administrator has set up in interactive website here.
Users can look up their recalled device's serial number to see what device payment award they may be entitled to by clicking here.
Those who return a recalled Philips machine by the August deadline are entitled to both the return and payment awards without having to submit a claim form and can use prepaid shipping labels by clicking here at no cost.
Those who spent their own money buying a comparable replacement CPAP or ventilator to replace a recalled device will need to complete a device replacement claim 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 claim submissions is Aug. 9, 2024.
The settlement does not impact or release any claims for personal injuries or medical monitoring relief, according to the administrator with the U.S. District Court for the Western District of Pennsylvania.
Roughly 30 million people have sleep apnea, a disorder in which one's airways become blocked during rest, interrupting breathing, according to 2022 data from the American Medical Association.
The company investigated all complaints and allegations of malfunction and serious injury of death, and "has found no conclusive data linking these devices and the deaths reported, Philips told CBS MoneyWatch on Thursday.
Kate GibsonKate Gibson is a reporter for CBS MoneyWatch in New York.
veryGood! (65)
Related
- Person accused of accosting Rep. Nancy Mace at Capitol pleads not guilty to assault charge
- 'Frasier' returns: Kelsey Grammer's premiere date, updated theme song revealed
- Windows are shattered in a Moscow suburb as Russia says it thwarts latest Ukraine drone attack
- Florida agencies are accused in a lawsuit of sending confusing Medicaid termination notices
- 'As foretold in the prophecy': Elon Musk and internet react as Tesla stock hits $420 all
- Knicks sue Raptors, allege ex-employee served as a mole to steal scouting secrets
- Bachelorette's Charity Lawson Joining Dancing With the Stars Season 32
- New president of Ohio State will be Walter ‘Ted’ Carter Jr., a higher education and military leader
- Residents worried after ceiling cracks appear following reroofing works at Jalan Tenaga HDB blocks
- Prosecutors prepare evidence in trial of 3 men accused in plot to kidnap Michigan Gov. Whitmer
Ranking
- Brianna LaPaglia Reveals The Meaning Behind Her "Chickenfry" Nickname
- Federal judge orders utility to turn over customer information amid reports of improper water use
- Prosecutors prepare evidence in trial of 3 men accused in plot to kidnap Michigan Gov. Whitmer
- About 30,000 people ordered to evacuate as wildfires rage in Canada's British Columbia
- New data highlights 'achievement gap' for students in the US
- Plane crashes into field in Maine with two people on board
- Tish Cyrus marries Dominic Purcell in Malibu ceremony 4 months after engagement
- The NFL's highest-paid guards in 2023: See the position's 2023 salary rankings
Recommendation
Woman dies after Singapore family of 3 gets into accident in Taiwan
'Rebel Moon' trailer: First look at Zack Snyder's new Netflix movie starring Sofia Boutella
Feds approve offshore wind farm south of Rhode Island and Martha’s Vineyard
Citing appeals court, Georgia asks judge to reinstate ban on hormone therapy for transgender minors
Who are the most valuable sports franchises? Forbes releases new list of top 50 teams
Caught in a gift card scam? Here's how to get your money back
4 firefighters suffer heat exhaustion at fire at vacant southern Michigan factory
When does 'American Horror Story: Delicate' come out? Everything you need to know.