The Food and Drug Administration said 561 deaths are reportedly tied to recalled sleep apnea devices made by Philips Respironics.
This comes as Philips Respironics this week agreed to stop selling new breathing machines in the US in a settlement with the FDA.
In June 2021, Philips Respironics recalled more than 5 million breathing devices after the company warned foam, which was meant to reduce noise, was breaking off and blowing into the mouths of users.
The FDA has received more than 116,000 medical device reports related to the foam breakdown.
In a statement released this week, Royal Philips CEO Roy Jakobs said, "Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and I acknowledge and apologize for the distress and concern caused. We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward."
In 2021, Philips Respironics, which produced more than 40% of the world's sleep apnea devices, agreed to replace all affected devices. However, the mishandling of the recall process left many patients without replacement devices for months and then many of the replacement devices were later recalled.
Janet Gray of White Settlement is one of the roughly 30 million people who have sleep apnea. Her C-PAP machine was one of the millions recalled by Philips Respironics.
"You are afraid to go to sleep because if you go to sleep without it, you might die but if you go to sleep with it, it might kill you down the road," Gray told the CBS News I-Team in a 2023 interview. "So I just sleep with it (C-PAP device) and pray."
Eighteen months after the recall, Gray received a refurbished replacement device but, by then, she said she had lost trust in the company.
In September, Philips Respironics agreed tousers of 20 different breathing devices. Claims for financial losses can now be submitted.
How to file a claim (from CBS MoneyWatch)
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.
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