“The FDA recently received medical device reports associated with thermal issues such as fire, smoke, burns, and other signs of overheating while people are using Philips DreamStation 2 CPAP machines,” the agency said.
In recent months, the FDA said it has seen an increase in the number of reports it has received regarding issues with the device. Between August and Nov. 25, more than 270 reports were received, compared to fewer than 30 in the past three years. Based on currently available information, the FDA believes the thermal issues reported may be linked to an electrical or mechanical malfunction, rather than the foam used in the machine, which was at the center of a June 2021 recall of an earlier version of the CPAP machine.
Patients and healthcare providers should carefully follow the manufacturer’s instructions when using the Philips DreamStation 2 CPAP machines and examine them before and after each use for any “unusual smells or changes in its appearance,” among other recommendations. The FDA did not recommend discontinuing use if there have not been overheating issues.
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