A survey of RVtravel.com readers showed nearly a third of those responding use CPAP machines. That can be a challenge for anyone, but for RVers, particularly those who boondock, the difficulty is multiplied. Using CPAP in an RV can be a real challenge. If that’s not all enough to worry about, now Philips, a major player in CPAP machine manufacturing, is stewing over yet another of its models creating potential harm for users.
Philips DreamStation 2 CPAP machine problems
No, we’re not referring to the debacle Philips Respironics dealt with a couple of years ago. In that sorry scenario, Philips had to recall millions of ventilators, bilevel positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. The fallout and lawsuits are certainly more than hip-deep for Philips. But now, a different line of CPAPs, DreamStation 2, is making news.
A November 28, 2023, announcement from the U.S. Food and Drug Administration (FDA) says there has been an uptick in medical device reports concerning the Philips DreamStation 2. The reports involve thermal issues. How’s that? Users report smelling smoke, getting burns, and having their machines catch fire.
Medical device reports (MDRs) are collected from manufacturers, device user facilities, and importers to monitor a machine’s safety. Between August 1 and November 15, 2023, Philips filed more than 270 MDRs about DreamStation 2 machines with the FDA. It’s a statistical fright. The agency had fewer than 30 MDRs receipted in the previous three years.
Do you use DreamStation 2?
If you use a DreamStation 2, look sharp. You need to monitor your machine closely for signs of overheating. DreamStation 2 devices that aren’t exhibiting issues can still be used while the FDA and Philips determine the exact cause for the problems.
“This is a developing situation, and to date, reports gathered and analyzed by the FDA indicate that the thermal issues reported for the DreamStation 2 CPAP machines may be related to an electrical or a mechanical malfunction of the machine, which may cause it to overheat in certain situations,” the agency said.
Philips — and FDA under scrutiny
It couldn’t come at a worse time for Philips. The DreamStation 2 issue comes while Philips is struggling to manage its June 2021 CPAP recall. Not only is the company in the soup dealing with victim legal settlements, Philips is also potentially handling a Justice Department Investigation. That’s because the media revealed that Philips kept secret more than 3,700 complaints about its faulty products for more than 11 years.
But it looks as though Philips isn’t the only one looking ugly with regard to its CPAP machine debacle. According to a report released earlier this week by ProPublica, the FDA may have seriously mishandled the earlier machine malfunction situation. Additionally, other medical devices that have gone haywire and injured, possible even killed, users have not been properly handled by the FDA, according to ProPublica. We urge you to read its lengthy, detailed, and frightening report here.
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Thank you, Russ and Tina! Yikes, very sad and disturbing news. However, as a former federal employee (Dept. of Energy, not FDA), I can attest to our ability to imperfectly do our jobs. Trying hard does not ensure perfect performance. (Failing to try hard can all but assure a bad outcome or set of bad outcomes.) Watchdog groups are necessary even though they, too, may sometimes get it wrong. The public can be too willing to rely on regulatory oversight to defend their best interests, hence the value of watchdog groups.
Not surprising that FDA‘s “warning letters” to manufacturers declined from 2016-2020.
My faith in the FDA (and a few more tri-letter agencies) has dropped precipitously in the past few years. Interesting article though.