As Philips still scrambles to wrap up its 2021 recall of more than 5.5 million ventilators and CPAP and BiPAP machines, a new issue has cropped up among another swath of its CPAP machines.
The FDA issued a safety communication on Tuesday warning users of DreamStation 2 devices that overheating may occur, potentially leading to fire, smoke, burns and more.
The warning came after Philips recently turned over to the FDA more than 270 medical device reports (MDRs) complaining about thermal issues with the CPAP machines, some of which reportedly detailed patient injuries. Though it submitted the reports between August 1 and November 15 of this year, they “cover a three-year period,” according to a statement from Philips, and follow “a retrospective review of possible thermal complaints related to DreamStation 2 since the launch of the product.”
The FDA said Philips had passed along fewer than 30 such complaints in the three years before this fall’s deluge of reports, dating back to the device’s clearance in July 2020.
The exact cause of the overheating is still under investigation by the FDA and Philips, but the regulator said its preliminary analysis of the MDRs suggests that it “may be related to an electrical or a mechanical malfunction of the machine, which may cause it to overheat in certain situations.”
“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,” Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in an agency release.
“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,” Shuren said.
For its part, Philips said in its statement that it’s currently “in discussions” with the FDA regarding the reports, adding, “Philips Respironics’ number one priority is patient safety and quality.”
As they continue looking into the issue, both the FDA and Philips have advised patients that they can continue to use their DreamStation 2 devices as long as they follow all safety instructions detailed in the CPAP machine’s user manual.
Those precautions include using the device only on a firm, flat surface away from flammable materials, keeping it clean and emptying its water tank when not in use—but only after letting the machine cool down for at least 15 minutes. Users should also monitor for unexplained changes in the device’s appearance and any unusual sounds or smells it may start to emit, and they should immediately unplug it and stop use if any occur.
The DreamStation 2 devices were not included in Philips’ still-ongoing June 2021 recall of many other respiratory support machines, though the FDA noted that some were sent out as replacements for the recalled devices.
That years-long recall has been centered on the polyester-based polyurethane foam used to muffle sounds and vibrations in certain devices, which has been found to be at risk of breaking down over time and potentially releasing chemicals and bits of debris into a user’s airflow.
DreamStation 2 machines, meanwhile, are manufactured using a different, silicone-based foam. The FDA said in this week’s safety communication that it doesn’t believe the overheating issues are related to the silicone foam.