Update from the Food and Drug Agency comes days after Philips said it would stop selling the devices in the U.S.
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.
But also they somehow thought they could get away with it in the usa when they declared themselves 2 years ago in France that the foam in their device gives cancer. I really can't understand the logic, usa is the country of trial and lawyers, they knew they would get sued at some point.
Be happy, you helped make some people at Phillip richer.
In all seriousness, Phillip itself admitted the foam in their device can make headache, give toxicity and cancer. I've not been able to read the official declaration, only news report but if I was you I would check that because when the company itself admit it can give cancer, you know it's bad.
This isnt even about the materials breaking down, every product breaks down eventually. But cars from 30 years ago have better critical air path separation than that.... how badly did they fuck up the engineering to even make it possible for housing components to get sucked into the intake?
Oh, it probably would have cost an additional $0.45 per unit to inject the housing in a different way that provides a hard barrier between the mechanicals and air intake so it got shitcanned...
I'm not sure, but your comment seems to imply an assumption that the foam was designed to be external to the air path and is getting unintentionally sucked in? That's not the case, the foam is literally only inside an "air chamber" that the air directly travels through.
Oh really ? Damn i was there last year and no different that other 3rd world. Rampant poverty, shitty roads etc. Mind it , I was not living in the city , city is developed but same is the case for all 3rd world countries.
I use another brand (Resmed) and pulled my old one apart to see what's inside. They are well engineered - and they need to be, as they run 7-8 hours, every night. They also have quite a bit of soundproofing surounding the pump. Mine had spray expanding foam and the spongy seat padding type, but this is all outside the airflow. I suppose they could use foam inside the air tubes for further sound damping, but it seems a bit dumb as if any breaks off it will go straight up your nose.
The FDA's regulation or lack thereof is partially a horror show. Not just for this. But all sorts of implants and techniques get grandfathered in and lead to partially horrific results for people.
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 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.
The tentative agreement, which must be approved by a U.S. court, calls for the company to keep servicing apnea machines already being used while stopping to sell new ones until specific conditions are met.
Claims for financial losses related to the purchase, lease or rent of the recalled machines can be now be lodged in the wake of a proposed class-action settlement reached in September.
Claims for financial losses related to the purchase, lease or rent of the recalled devices can be made, with eligible users entitled to:
Roughly 30 million people have sleep apnea, a disorder in which one's airways become blocked during rest, interrupting breathing, according to 2022 data from the American Medical Association.
The original article contains 515 words, the summary contains 180 words. Saved 65%. I'm a bot and I'm open source!
Rubbish summary. My first question was "how can a device that basically forces you to breathe, kill you?"
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.
Polyester-based polyurethane foam used in the devices to reduce sound and vibration can break down, with black pieces of foam or invisible chemicals that can be breathed in or swallowed by the person using the device. "These issues could potentially result in serious injury and require medical intervention to prevent permanent injury," the FDA stated.