The U.S. Food and Drug Administration (FDA) is warning patients and health care providers to carefully monitor Philips DreamStation 2 CPAP devices for signs of overheating.
The FDA issued a safety warning on Nov. 28 saying that it recently received medical device reports associated with thermal issues such as fire, smoke, burns and other signs of overheating while people are using a Philips DreamStation 2. The agency observed a recent increase in reports about these issues with DreamStation 2s. 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 reports received in the previous three years.
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 said it does not believe the safety issue with the DreamStation 2 is related to the foam used in the machine.
“The FDA is committed to assuring this new safety issue is resolved expeditiously. We will continue to monitor the company’s handling of this, among other safety issues, to ensure they take appropriate steps to mitigate the risk to patients,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “We share the public’s concerns regarding the new and continued safety issues of CPAP machines and certain recalled medical devices manufactured by Philips. Addressing these safety concerns remains a top priority for the FDA.”
The agency said the situation is developing but that the reports indicate that the thermal issues reported may be related to an electrical or a mechanical malfunction of the machine, which may cause it to overheat in certain situations.
Both Philips Respironics and the FDA said they were in talks about the matter.
Philips said it filed the 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 in a statement released Nov. 29
"Philips Respironics’ number one priority is patient safety and quality," the company said. "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."
Philips Respironics also said it conducted a review and analysis regarding reports of the possible thermal issues in accordance with its regulatory processes. The devices can continue to be used provided that the safety instructions are followed.
The FDA said users should take the following steps:
- Follow the manufacturer’s instructions in the user manual external link disclaimer, including:
- place the CPAP machine on a firm, flat surface
- keep the CPAP away from carpet, fabric, or other flammable materials
- carefully clean the CPAP machine
- empty the CPAP machine’s water reservoir
- let the CPAP machine’s heater plate and water tank cool for approximately 15 minutes before removing the tank to reduce the risk of burns. You could be burned if you touch the heater plate, come in contact with the heated water, or touch the humidifier water tank pan.
- Inspect and examine the CPAP machine before and after each use for unusual smells or changes in its 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.
- Unplug the CPAP machine and do not use it if:
- you smell burning, smoke, or any unusual odors,
- there is a change in the appearance of the CPAP machine,
- there are unexplained changes to the CPAP machine’s performance,
- water is spilled into the CPAP machine,
- you hear unusual sounds coming from the CPAP machine.
If patients are unable to use their CPAP device due to these issues they should discuss their situation with a care provider such as a primary care physician or sleep doctor. If there are no issues, the FDA does not recommend discontinuing use of these machines.
Report any concerns about the CPAP machine to the FDA, including unusual smells, sounds or changes in appearance, and report any concerns to Philips' External Link Disclaimer.
The FDA said it is in ongoing discussions with the company about mitigation strategies for this safety issue and will update the public accordingly.