FDA Warns of Safety Issues with Philips' DreamStation 2 CPAP Machines

The U.S. Food and Drug Administration (FDA) has issued a safety communication regarding Philips Respironics' DreamStation 2 CPAP machines used for treating obstructive sleep apnea. The FDA has received reports of thermal issues with the machines, including fire, smoke, burns, and overheating, leading to patient injuries. The agency is in discussions with Philips about mitigation strategies and is urging users to carefully monitor the machines for signs of overheating. This safety issue is separate from the June 2021 recall of Philips sleep therapy and respirator machines. The FDA believes the thermal issues may be due to electrical and/or mechanical malfunctions and will provide updates as more information becomes available.