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FDA says 561 deaths tied to recalled Philips sleep apnea machines (www.cbsnews.com)

submitted 9 months ago by MicroWave to c/health

17 comments fedilink hide all child comments

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.

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[–] FollyDolly 3 points 9 months ago (2 children)

Well this scary as fuck. My husband is going to be tested for sleep apnea soon and now I really hope he doesn't have it.

[–] [email protected] 4 points 9 months ago

These deaths and the recall are specifically tied to particles from foam used for sound insulation that broke down.

First month or so with a machine is a bit of adjustment but otherwise they are generally safe and add literal years to the life of a user.

I agree the situation described in the link is terrifying but long term, sleep apnea is far more dangerous than treating it. I can’t recall another instance of serious illness or death tied to CPAP equipment aside from this one.

All the best to your husband, best case he either doesn’t have it or it’s very minor.

If the doc points you to a supplier for a machine, you are NOT obligated to use that supplier. Whether they only sell Philips, or you just don’t like the color of their building, you can and may ask for a prescription from the doctor and choose a supplier you feel comfortable with.

[–] [email protected] 2 points 9 months ago

I have a couple of relatives who use ResMed machines and are pretty happy with them. There are other vendors.