Philips CPAP and BiPap machines that were recalled in 2021 have since been linked to deaths and thousands of malfunctions, the FDA says
The Food and Drug Administration announced this week that previously recalled sleep apnea machines have been linked to the deaths of 561 people.
In June 2021, the agency announced a recall of Philips Respironics BiPAP and CPAP machines — devices worn overnight while someone sleeps — as well as ventilators, saying the “polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway.”
Since that initial recall, the FDA says it has received “561 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown.”
As the agency noted in its initial alert, “black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.”
BiPap and CPAP machines are worn at night to help those with sleep apnea, which the Cleveland Clinic explains is “is a disorder that causes you to stop breathing while asleep. Your brain tries to protect you by waking you up enough to breathe, but this prevents restful, healthy sleep.”
Both machines operate by delivering pressurized air through a mask worn over the face while sleeping.
Since the recall, the FDA has received more than 116,000 reports of foam breaking down in the machines.
More than 5 million devices were affected by the recall, CBS News reported, and Philips attempted to repair them at first; However, those machines were eventually recalled as well.
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If you have a Philips breathing machine, you can look up the serial number on this website — which will also let you know if you’re eligible to be a part of a class action suit against the manufacturer.
A National Institute of Health study said that an estimated 1 billion people are affected globally by sleep apnea.
It’s usually diagnosed by an overnight sleep study — although there are home tests that can be performed.
Apart from frequently waking at night, those with sleep apnea wake up tired, and may experience depression and anxiety, the Cleveland Clinic explains.
Snoring is also a common symptom of sleep apnea — but not everyone who snores has the disorder.
Apart from using a night-time device, the Cleveland Clinic says those with sleep apnea can help the condition by trying nasal sprays, adhesive strips, and for those with excess weight or obesity, a 10% reduction in weight can “significantly improve sleep apnea.”
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