(NewsNation) — People have reported the Philips Respironics DreamStation 2 CPAP machines can overheat, smoke and even catch fire while in use, the Food and Drug Administration warned in an alert issued earlier this week.
FDA regulators said it has seen a recent increase in medical device reports associated with “thermal issues such as fire, smoke, burns and other signs of overheating” while people are using the CPAP machines. Between Aug. 1 and Nov. 15 the FDA received more than 270 reports of problems associated with the device compared with fewer than 30 MDRs from the previous three years, according to the alert.
A CPAP, or continuous positive airway pressure machine, is used for breathing disorders such as sleep apnea. Using mild air pressure, it keeps people’s breathing airways open while they sleep, according to the National Heart, Lung and Blood Institute.
Some DreamStation 2 CPAP machines were distributed to replace recalled DreamStation 1 CPAP machines. About 10.9 million of the DreamStation 1 machines were recalled two years ago because of complaints of degraded foam releasing harmful gases and particles into users’ airways, according to the AARP.
Currently available evidence does not show the safety issue with the DreamStation 2 is related to foam in the machine, the FDA says. Reports analyzed by the agency indicate that the reported thermal issues might be related to an electrical or mechanical malfunction.
The FDA is now working with Philips to better understand the issue and possible underlying causes, the agency said.
“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 Dr. 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.”
Philips said in its own statement that patient safety and quality is their number one priority, and confirmed it’s in “discussions” with the FDA.
“Philips Respironics 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 in the instructions for use for the DreamStation 2 sleep therapy device are followed,” the release said.
The FDA recommends patients, caregivers and health care providers using the CPAP follow the manufacturer’s instructions in the user manual.
This includes:
- placing the CPAP on a firm, flat surface
- keeping it away from flammable materials like carpet or fabric
- carefully cleaning the machine
- emptying the CPAP’s water reservoir
- letting the heater plate and water tank cool for 15 minutes before removing it
- inspecting the CPAP before and after each use for unusual smells, changes in its appearance
According to the FDA, the CPAP should be unplugged and not used if
- you smell burning, smoke or any other unusual odors or hear unusual sounds coming from it
- see a change in its appearance
- there are unexplained changes to the machine’s performance
- water is spilled on the CPAP
Those unable to use the CPAP device because of these issues should discuss their situation with a health care provider, the FDA said, and report any concerns to the FDA and Philips.