A total of 561 deaths have been reported in connection with machines to help people suffering from obstructive sleep apnea manufactured by the company Philips, which were withdrawn from the market, the Food and Drug Administration (FDA) reported.
According to the FDA, since April 2021 there have been more than 116,000 reports that pieces of foam and gases were expelled from Philips CPAP (Continuous Positive Airway Pressure) machines and BiPAP sleep therapy devices.
The Dutch company decided to recall millions of these machines after reports that
pieces of foam and gases
had traveled into the airways of people who used them, CBS News reported.
Jeffrey Reed, a patient who experienced constant infections and two pneumonias while using the Philips CPAP machine, at his home in Marysville, Ohio, on January 29, 2024. Associated Press
The company announced last Monday that it was going to stop selling the devices in the United States, under a provisional agreement with regulatory authorities that could cost it nearly $400 million, The Associated Press reported.
Device maker Philips has recalled more than 5 million pressurized respirators due to the risk of their internal foam breaking down over time.
The company first announced the problem in mid-2021, but efforts
to repair or replace the machines
have dragged on for years, frustrating patients in the United States and other countries.
[The Secretary of Health says that the proposed reduction in medicine prices will be "something historic"]
The Dutch medical equipment giant has announced that it has agreed to a consent decree with the FDA and the Department of Justice.
The agreement has not yet been closed and must be approved by a US judge.
Philips officials announced the provisional agreement during the presentation of quarterly earnings results.
Under the terms of the agreement, Philips would continue to service machines previously sold in the United States, but would not be able to sell new ones until it complies with corrective measures established by the FDA.
Company executives said they have set aside $393 million for operational changes and necessary modifications.
The company promised that it puts "safety and quality at the center of everything we do, with a higher level of responsibility," Philips CEO Roy Jakobs told market experts and investors, quoted by The Associated Press.
The FDA website warned patients that the risks of ingesting the sound-deadening foam could include headache, asthma, allergic reactions and more serious problems.
In November, the agency issued a new warning that
the machines can overheat
and, in rare cases, cause fires.
Philips reached an agreement at the end of 2023 to pay at least $479 million in compensation for people who used 20 breathing devices and ventilators, which were sold in the United States between 2008 and 2021.
It was reported that those who file claims for losses related to the purchase or rental of the recalled devices may receive financial compensation for each device purchased or rented;
a payment of $100 for each machine returned before August 9, 2024, or compensation to purchase a similar machine from June 14, 2021 and before September 7, 2023, CBS News said.
[The oldest family in the world has this meal for lunch every day]
The administrator of the agreement created a website where the requirements to benefit from it are specified and a form is included to proceed with payments or replacement of the machines.
People who wish to fill out the paper form can do so on this internet portal.
Users can search for the serial number of their recalled device to find out about the payment they are entitled to on this website.
Those who return a recalled Philips device before the August deadline will be entitled to both a refund and payment and will not need to submit a claim form.
These people – CBS News specified – will be able to use prepaid shipping labels.
People can also call 1-855-912-3432.
The understanding
does not affect or relieve any claim for personal injury
or compensation for medical reasons, the administrator of the agreement indicated before the District Court for the Western District of Pennsylvania, CBS News reported.