Maker of recalled sleep apnea machines agrees to halt sales in US

[dalton99a]

https://apnews.com/article/sleep-apnea-machines-recall-philips-fda-safety-71686627ce41a8625a98449a61f63a0b

Maker of recalled sleep apnea machines agrees to halt sales in US
By MATTHEW PERRONE
Updated 2:54 PM CST, January 29, 2024

WASHINGTON (AP) — The company behind a global recall of sleep apnea machines said Monday it will stop selling the devices in the U.S., under a tentative agreement with regulators that could cost the manufacturer nearly $400 million.

Device maker Philips has recalled more than 5 million pressurized breathing machines due to risks that their internal foam can break down over time, leading users to inhale tiny particles and fumes while they sleep.

The company first announced the problem in mid-2021, but efforts to repair or replace the machines have dragged on for years, frustrating patients in the U.S. and other countries.

The Dutch manufacturing giant said it has agreed to a consent decree with the Food and Drug Administration and the Department of Justice. The deal has not yet been finalized and will have to be approved by a U.S. judge. Philips executives disclosed the tentative agreement during a quarterly earnings update.

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[Hekate]

1. Mine is ResMed, but this ongoing problem really makes me uneasy...

My apnea persists after weight loss, and it’s probably at least partly rooted in my brain. And asthma. And whatever. The hell — I need this medical device, and it needs to be safe and reliable.

[Ms. Toad]

2. Dang.

They are the makers of my daughter's device. Her sleep apnea is mild enough that she had to be tested twice to qualify for the device. She has an underlying chronic illness that leaves her exhausted most of the time. Any disruption in her sleep - even very minimal - has a much more significant impact on her well-being than it would on a person who didn't have her health complications.

The CPAP made the difference between it taking me 30-45 minutes to wake her up every morning, since the alarm clock did no good to waking herself up instantly every morning with an alarm clock I don't even hear - even when I'm in the same room as she is. It really is a miracle.

But - because her sleep apnea is so mild, she may not qualify if she needs a prescription for a new machine. Phillips sent her a replacement for their last recalled device, so she didn't need a new prescription. But if Phillips is out of the game, her choices are sleeping with a device that may be hazardous to her health - or returning to sleeping without one.

[mahina]

4. There's a new take home sleep test

She may get better results with that if she’s able to sleep at home. The only downside is you leave the doctors office looking like across between an escaped hospital patient and a person strapped up with a bomb with wires all over you and electrodes, but it’s not that uncomfortable at all really. I got enough sleep with it on to be diagnosed after having a result like her in the sleep study office. The first time. Like the posters above I too have a res med machine , just got through night three, and it seems pretty safe. Wishing her luck and you as well .

[Ms. Toad]

5. Unfortunately, the CPAP she uses (or the one this one replaced)

tests for apnea at home. She sleeps on her side at home, and she has far fewer incidents on her side during what ever period they tested her at home. So she's fighting an uphill battle to get a new prescription.

Guess we'll cross that bridge when we come to it.

[LetMyPeopleVote]

3. I have a ResMed machine