The U.S. Food and Drug Administration (FDA) is warning patients and health care providers to carefully monitor Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating.
The FDA recently received medical device reports (MDRs) 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 observed a recent increase in reports about these thermal issues with DreamStation 2 CPAP machines. Between August 1, 2023, and November 15, 2023, the FDA received more than 270 reports of problems associated with the device, compared with fewer than 30 MDRs received in the previous three years.
The FDA said consumers should be aware some DreamStation 2 CPAP machines were distributed as replacements for recalled DreamStation 1 CPAP machines. Based on the currently available evidence, the agency does not believe the safety issue with the DreamStation 2 is related to the foam used in the machine. 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.
Philips Respironics said it is in discussions with the FDA regarding the reports it filed with the FDA related to possible thermal issues in the humidifier of the DreamStation 2 sleep therapy device while in use. Philips Respironics filed these approximately 270 reports over the last three months which cover a three-year period following a retrospective review of possible thermal complaints related to DreamStation 2 since the launch of the product.
The company said the devices can continue to be used provided that the safety instructions in the instructions for use for the DreamStation 2 sleep therapy device are followed.
The Philips DreamStation 2 CPAP machine delivers positive airway pressure for treatment of obstructive sleep apnea. It is used at home and in clinical settings.