FDA says 561 deaths tied to recalled Philips sleep apnea machines
FDA says 561 deaths tied to recalled Philips sleep apnea machines
Update from the Food and Drug Agency comes days after Philips said it would stop selling the devices in the U.S.
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.
Shout-out to ProPublica for their relentless efforts to bring this to light, like https://www.propublica.org/article/philips-kept-warnings-about-dangerous-cpaps-secret-profits-soared
60At one time Phillips was a well respected brand. Their domestic appliances division was acquired by Hillhouse, the same private equity firm that partially owns Tencent and Zoom. I'm not sure if they also manufacturer the sleep machines but after being a Hue and Norelco customer for years I won't give them another dime.
17No, this is the 'original' Phillips, that is now focussed on medical devices. And hue lights are (confusingly) produced by yet another seperate former piece of Phillips: Signify, the former lighting devision.
5
And here I was thinking about getting one to improve my sleep… I’m a bit torn on whether death is an improvement.
15I had a Philips Dreamstation that was recalled. I'm not sure exactly what happened but I started having an issue where I would feel extreme euphoria at random times throughout the day when I inhaled. It only happened when I used the Dreamstation. If I used my travel CPAP or my replacement Airsense, I had no problems.
I saw my PCP about it and we never figured it out. And again, it stopped when I switched devices.
I don't know what gases were being released but there's got to be a correlation.
15The reason for the recall is due to the sound insulation material breaking down and being breathed in.
This certainly should not cause euphoria :?
5Dunno doesn't sound too bad to me
1Not a bug, it's an undocumented feature.
7
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.
3These 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.
4I have a couple of relatives who use ResMed machines and are pretty happy with them. There are other vendors.
2