FDA Links 561 Deaths to Recalled Philips Sleep Apnea Machines

The FDA has said Philips is to pay a $400 million settlement over recalled sleep apnea machines linked to 561 deaths.

CBS News reports that the U.S. Food and Drug Administration (FDA) has reported that 561 deaths have been linked to recalled Philips respirators and ventilators used to treat sleep apnea and other breathing issues. This statistic comes as Philips agrees to pay $400 million to settle a lawsuit over the defective devices.

Philips initially recalled millions of Continuous Positive Airway Pressure (CPAP) machines and Bi-Level Positive Airway Pressure (BiPAP) devices in June 2021 after customers complained the foam inside was degrading and entering airways. The company later recalled repair kits meant to fix the problem as well.

According to the FDA, since April 2021 it has received over 116,000 reports of the recalled machines’ foam breaking down and releasing hazardous particles. This includes 561 reports of deaths potentially tied to use of the devices.

In a statement, Philips said it has “found no conclusive data linking these devices and the deaths reported.” However, the company will pay $400 million under a proposed legal settlement with the Justice Department and stop selling the machines in the U.S. until specific safety conditions are met.

The settlement also includes a $479 million payout to compensate affected U.S. customers. Individuals may file claims for financial losses related to purchasing or renting the recalled products. There is also a $100 return award for sending back a recalled device by August 2024.

Roughly 30 million Americans suffer from sleep apnea, which causes breathing to stop repeatedly during sleep. Patients rely on CPAP machines to deliver constant airflow to keep airways open.

The potential risks of these widely-used Philips devices has raised alarms among consumer advocates. Though Philips argues the settlements do not indicate liability, Diana Zuckerman of the National Center for Health Research believes “hundreds of deaths could have been prevented if the FDA had done its job properly.”

Users can check if they’re eligible for a device payment award by looking up their device’s serial number here. Customers who return a recalled Philips machine by August will receive return and payment awards without submitting a claim form. Prepaid shipping labels are available here at no cost.

If you have purchased a replacement CPAP or ventilator using your own money to replace a recalled device, then you will need to fill out a device replacement claim form in order to get reimbursed. You can find the claim form online here or you can get a paper form by applying here.

Read more at CBS News here.

Lucas Nolan is a reporter for Breitbart News covering issues of free speech and online censorship.