Company that made millions of defective sleep apnea machines ordered to overhaul manufacturing

[Eugene]

Source: Associated Press

WASHINGTON (AP) — The company responsible for a global recall of sleep apnea machines will be barred from resuming production at U.S. facilities until it meets a number of safety requirements, under a long-awaited settlement announced Tuesday by federal officials.

Philips will be required to overhaul its manufacturing and quality control systems and hire independent experts to vet the changes, according to a court order announced by the U.S. Department of Justice. The company must also continue to replace, repair or provide refunds to all U.S. customers who got the defective devices, the department said.

The action is a major step toward resolving one of the biggest medical device recalls in history, which has dragged on for nearly three years.

Most of the devices recalled are continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep mouth and nasal passageways open during sleep. Left untreated, sleep apnea can lead to dangerous drowsiness and increased risk of heart attack.

-snip-

BY MATTHEW PERRONE
Updated 7:10 PM EDT, April 9, 2024


Read more: https://apnews.com/article/cpap-sleep-apnea-philips-lawsuit-fda-229c8959b4ccbda015b1fad42f7477af

[ificandream]

1. K&R.

As one of the millions of Americans (including President Biden) who have obstructive sleep apnea, thanks.

[BlueKota]

2. Thank you.

I use a CPap machine. This is from a different manufacturer than mine, but I feel bad for the people who have the defective ones.

[ificandream]

4. I don't use Philips machines either, but I've used their masks.

The masks seemed to be OK, but my provider recently changed me to a non-Philips mask and it seems to be working better.

[Probatim]

6. Which mask do you use? I use an Amara View and it works pretty well.

Thanks!

[ificandream]

7. I was using Philips Dreamwear until about three weeks ago.

Right now, I'm using the ResMed F30i. Seems to be working out better for me. I had been waking up very tired with the Dreamwear. That's happening a lot less with the ResMed. My machine is a ResMed, too.

[Probatim]

8. Thanks again - good to hear what others find to be working well.

[ificandream]

3. DOJ press release link

https://www.justice.gov/opa/pr/court-enjoins-philips-respironics-manufacturing-and-distributing-adulterated-and-misbranded

[truthisfreedom]

5. Resmed all the way!

Very happy with mine. Lifesaving.

[Puppyjive]

9. $10 neck pillows work just fine

I bought a memory foam neck pillow for traveling. It not only keeps my airway open, it prevents teeth grinding. I use it all the time. I have mild sleep apnea. Way more affordable then the machines.

[JustABozoOnThisBus]

11. Does the neck pillow keep track of how often you stop breathing while sleeping?

And does it report the data to a MD who specialises in sleep abnormalities?

I'd guess a neck pillow is as effective as a MyPillow, or just sleeping with an ultraviolet light inserted into some bodily orifice.

I'll go with the Dr's advice and use the machine.

[Puppyjive]

12. Just did a sleep study

I've done 2 sleep studies and paid $3000 for a dental device that caused me a lot of dental pain. I used my neck pillow in my latest sleep study. The good news is i don't need a machine according to the results.

[Puppyjive]

13. I'm not a doctor

It just works for me. I will do anything to avoid the machine.

[LudwigPastorius]

10. Awww man!

All that quality control and safety is gonna cut in on their profit!