Over 560 deaths related to recalled Phillips sleep apnea machines, FDA claims

05 February 2024 , 09:51

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Over 560 deaths have been reported in connection with recalled Phillips devices

Over 560 deaths have been reported in connection with recalled Phillips devices designed to treat sleep apnea and other breathing disorders, the Food and Drug Administration (FDA) reports.

Since April 2021, more than 116,000 reports have been made of foam breaking down in Phillips’ BiPAP and CPAP (continuous positive airway pressure) machines. This includes 561 reported deaths.

This comes just days after the Dutch medical manufacturer said it would stop selling the machines in the United States after agreeing to a $400 million settlement with the Justice Department and FDA. Phillips has been forced to recall millions of breathing devices following a slew of reports the machines were blowing foam into users’ airways.

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A man sleeps with a CPAP machine in bed to treat his sleep apnea, a condition where breathing repeatedly stops and starts during sleep.

The polyester-based polyurethane foam used in these breathing machines, designed to reduce sound and vibration, can break down, sending chemicals and other harmful debris down the airways of the machines’ users. The FDA said: “These issues could potentially result in serious injury and require medical intervention to prevent permanent injury.”

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The $400 million agreement, which is still to be approved by US courts, calls on the Dutch company to keep servicing machines currently on the market while halting the sale of new devices until specific conditions have been met.

Phillips announced an initial recall to repair and replace devices in June 2021, with approximately 5.5 million machines returning to the company. It would then go on to agree a payment of at least $479 million to compensate users who purchased 20 different breathing devices between 2008 and 2021.

CPAP machine with air hose and head mask

As of a proposed class-action lawsuit in September 2023, claims of financial losses connected to the purchase, rent, or lease of select Phillips machines can be lodged here.

If your claim is successful, you could be awarded:

• A Device Payment Award for each Recalled Device they purchased, leased, or rented.

• A Device Return Award of $100 for each Recalled Device they purchased, leased, rented, or were prescribed that they have already returned or that they return to Philips Respironics by August 9, 2024; and/or

• A Device Replacement Award if they spent their own money to purchase a comparable CPAP, BiPAP, or ventilator on or after June 14, 2021 and before September 7, 2023 to replace a Recalled Device.

Over 30million Americans suffer from sleep apnea

The claims period ends on August 9, 2024. If you wish to make a claim, you can see if your device qualifies . Phillips claims it "has found no conclusive data linking these devices and the deaths reported".

Around 30 million Americans suffer from sleep apnea, a condition that causes a person’s airways to become blocked during sleep, according to the American Medical Association.

Henry Moore