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FDA says 561 deaths tied to recalled Philips sleep apnea machines
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.
President-elect Donald Trump tapped Republican Brendan Carr, an Elon Musk-backed critic of big tech, to lead the Federal Communications Commission (FCC), calling Carr a “warrior for Free Speech” in a statement on Sunday.
Carr has “fought against the regulatory Lawfare that has stifled Americans’ Freedoms” and will “end the regulatory onslaught that has been crippling America’s Job Creators and Innovators, and ensure that the FCC delivers for rural America,” Trump said in the statement.
Carr said on Musk’s social platform X that he was “humbled and honored” to take on the role of FCC chairman.
“We must dismantle the censorship cartel and restore free speech rights for everyday Americans,” he wrote in another post Sunday.
Alex Wong / AP
It is a phrase he has used repeatedly, posting on Friday: “Facebook, Google, Apple, Microsoft & others have played central roles in the censorship cartel,” adding that it “must be dismantled.”
Carr was already the senior Republican on the FCC, an independent agency that regulates licenses for television and radio, pricing of home internet, and other communications issues in the United States.
The five-person commission will have a 3-2 Democratic majority until next year, when Trump will get to appoint a new member, The Associated Press points out, adding that Carr has also been the commission’s general counsel and was confirmed unanimously by the Senate three times and nominated by both Trump and President Biden to the commission.
Long rumored as a contender for FCC chair, he has built an alliance with billionaire Musk — Trump’s wealthiest backer, whose Starlink satellite internet service could benefit from access to federal cash.
The New York Times reported that Starlink received an $885 million grant in late 2020 from the FCC — but that the Democrat-led commission later revoked it because the service couldn’t prove it would reach enough unconnected rural homes.
Carr “vociferously” opposed the decision, the newspaper reported.
“In my view, it amounted to nothing more than regulatory lawfare against one of the left’s top targets: Mr. Musk,” he wrote in a Wall Street Journal opinion article last month.
Carr has also publicly agreed with the incoming Trump administration’s promises to slash regulation and punish television networks for what they say is political bias.
Trump has repeatedly called to strip major broadcasters such as ABC, NBC and CBS of their licenses.
During the 2024 campaign, he singled out CBS, saying its license should be revoked after its flagship news program “60 Minutes” aired an interview with his Democratic opponent, Kamala Harris. Trump had declined to sit for a similar interview.
Trump sued CBS News, alleging the network’s “deceitful” editing of the 60 Minutes interview of Harris misled the public and unfairly disadvantaged him. In a statement, CBS News called the former president’s claims “completely without merit” and said the network intended to vigorously defend against the lawsuit.
Carr also wrote a chapter on the FCC in the controversial Project 2025 document that purported to lay out a vision for a second Trump administration, in which he also called for the regulation of the largest tech companies, such as Meta, Google and Apple.
The FCC needs to bring new urgency to four main goals: reining in big tech, promoting national security, “unleashing” economic prosperity and ensuring FCC accountability, he wrote in the document by the conservative Heritage Foundation.
Carr was a strong foe of the FCC’s reinstatement in April of landmark net neutrality rules that were repealed during the first Trump administration, the Reuters news agency notes. The Biden FCC rules were in turn put on hold by a federal appeals court.
Two people were killed and 10 others were wounded in two separate shootings along a New Orleans parade route and celebration attended by thousands on Sunday, authorities said. There were no immediate arrests.
Officers responding to reports of gunfire shortly after 3:30 p.m. on an avenue in the city’s St. Roch neighborhood found eight victims with gunshot wounds, according to a news release from the New Orleans Police Department. All eight were taken to hospitals in unknown condition. Police later said a ninth wounded person arrived at a hospital via a private car.
CBS New Orleans affiliate WWL-TV reports that, according to investigators, ballistics showed that two shooters were involved.
About 45 minutes later, police received another report of gunfire as revelers were crossing the Almonaster Avenue Bridge, just over half a mile (.8 km) to the north. One person died at the scene and another died at a hospital, police said. A third victim was driven to a hospital in a private vehicle and was in stable condition, police said.
No arrests were announced and no suspect information was released.
The St. Roch neighborhood is several blocks northeast of the city’s French Quarter that is popular with tourists.
The Almonaster Bridge was closed in both directions during the investigation.
Police Superintendent Anne Kirkpatrick said detectives didn’t immediately know if the incidents were related.
“They were … different kinds of approaches,” she said of the shootings, which occurred in the area where a “second line,” a celebration following a parade, was taking place.
Thousands had gathered for the annual outing of the Nine Times Social Aid & Pleasure Club in the 9th Ward, organizer Oscar Brown told NOLA.com.
“It is a wonderful event, and we want to keep it a wonderful event,” Kirkpatrick said.
It was the second major shooting in the South since gunfire marred a homecoming weekend at Tuskegee University in Alabama on Nov. 10, leaving one person dead and injuring 16 others, a dozen of them by gunfire, authorities said.
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