On November 28, the FDA published a Safety Communication about a risk of burn injuries and fires from certain Philips DreamStation 2 CPAP machines used for sleep apnea.
The FDA said there have been around 300 reports involving the Philips DreamStation 2 CPAP machines overheating, including fires, smoking, and burns suffered by people who were using the device.
The FDA also warned that there has been a sharp increase in the number of DreamStation 2 devices overheating since August 2023, which may be related to an electrical issue or mechanical malfunction.
Philips Respironics introduced the DreamStation 2 when the company issued a massive recall for CPAP machines in June 2021 due to toxic sound-abatement foam and gases that could cause health issues.
Some of the machines linked to overheating issues were distributed as replacement machines for people who were affected by the June 2021 recall, according to the FDA Safety Communication.
The FDA said that “this is a developing situation … the thermal issues may be related to an electrical and/or a mechanical malfunction of the machine, which may cause it to overheat in certain situations.”
Philips is currently facing thousands of lawsuits from people who developed health problems as a result of toxic foam and gases in their recalled breathing machines.
Lawsuits claim that Philips delayed issuing a recall or warning consumers about the health risks of breathing the toxic foam until after it had finished developing the DreamStation 2 CPAP machines.