The medical device safety agency said it recently received an influx of medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs of overheating while patients were using the devices.
It’s the latest safety warning for Philips respiratory devices, of which more than 5 million have been recalled for dangerous degradation of sound abatement foam. At least 385 deaths have been reported in connection with the foam-related recall.
“Consumers should be aware some DreamStation 2 CPAP machines were distributed as replacements for recalled DreamStation 1 CPAP machines,” the FDA said.
The agency is working with Philips to learn more about the problems, causes and mitigation strategies.
“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,” the FDA said. “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.”
DreamStation 2 CPAP machines treat obstructive sleep apnea at home and in clinical settings.
Philips said the problems may be connected to the device’s humidifier, but has not yet said whether it has initiated a recall for the latest issue or whether it plans to.
“Philips Respironics’ number one priority is patient safety and quality,” the company said in a statement to MassDevice. “Philips Respironics 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.”
The FDA said it received more than 260 reports of such problems from Aug. 1, 2023, to Nov. 15, compared to fewer than 30 reports of thermal issues in the last three years.
Philips said it “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 FDA has issued recommendations for patients and health care providers about the overheating problem, including inspecting and examining CPAP machines before and after each use to smell for unusual odors and look for changes in the device’s appearance.
“Some problems may only be noticeable when the machine is running, so pay attention to any differences in the CPAP machine as you prepare for bed, before you fall asleep,” the FDA said.
The FDA directed users to unplug and stop using any CPAP machines if they smell burning, smoke, or any unusual odors; hear unusual sounds coming from the devices; or notice a change in the appearance of the machine or unexplained changes in its performance. Users should also unplug and stop using the machines if water is spilled into them.
The FDA also told users to follow the instructions in the user manual, including giving the CPAP machine’s heater plate and water tank about 15 minutes to cool before removing the tank.
“You could be burned if you touch the heater plate, come in contact with the heated water, or touch the humidifier water tank pan,” the FDA warned.
The FDA is not recommending patients stop using their machines unless they experience one of the above problems.
