Stock photo of a sleep apnea machine. Source
Sleep apnea affects as many as 1 in 15 Americans and causes side effects such as snoring, headaches, depression, and daytime sleepiness.
Sleep apnea machines work by delivering a stream of oxygenated air to airways via a mask and tube.
Recently, news reports revealed that more than 500 deaths have been linked to machines made by one particular company.
Recalled Philips Machines Linked to Hundreds of Deaths
A notice of Medical Device Reports (MDRs) was posted to the FDA’s website, detailing 116,000 reports and 561 deaths linked to the devices.
The machines have been made from PE-PUR foam, which has been found to break down over time and enter the airways of some sleep apnea machine patients, according to a report from USA Today.
Five million devices were recalled in 2021 as Philips attempted to fix the issue.
Philips Responds to FDA Accusations
The company has since agreed to stop selling the devices and a proposed class action settlement is now underway.
Its official position is that ‘no conclusive data’ has been found linking these devices.
“Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in these medical device reports,” the USA Today report stated.
“Importantly, the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event. Philips Respironics investigates all received complaints and allegations of malfunction, serious injury or death.”
A list of recalled machines of various types is listed on the FDA’s website here.
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