FDA warning again for Philips sleep apnea device

The American regulator FDA has again warned about problems with sleep apnea devices from Philips. This time it concerns overheating of the DreamStation 2.

The devices can cause fire, smoke and burns, reports the supervisor. Between August and mid-November, 270 reports of such problems were reported, a “strong increase” according to the FDA. Patients and caregivers who work with the DreamStation are advised to carefully check the machines for unusual odors.

The DreamStation 2 was not included in the massive recalls in which Philips has had to repair millions of defective sleep apnea devices since 2021 because insulation foam could come loose.

The problems with those machines, which support patients’ breathing at night, have cost the company hundreds of millions of euros. In addition, there are still claims for damages from injured patients and more financial consequences due to a possible settlement with the American authorities.

The FDA notes in its warning that some patients actually received the DreamStation 2 as a replacement for their defective device. The American watchdog does not assume that the problems with the DreamStation 2 are also related to crumbling insulation foam.