WASHINGTON — A device made by Philips Respironics for treating sleep apnea should be monitored closely when in use because it can overheat, according to federal regulators.
The Food and Drug Administration warned Tuesday that Philips' DreamStation 2 can start to smoke or even begin burning while in use. The FDA said it received 270 reports of problems with the company's continuous positive airway pressure (CPAP) machine between August and November 15. The issue "may be related to an electrical or a mechanical malfunction of the machine, which may cause it to overheat in certain situations," the FDA said.
To reduce the chances of the DreamStation 2 overheating, users should regularly clean the device, put it on a flat surface and keep it away from flammable materials when in use, the FDA said. Consumers should unplug the machine when it is not in use, empty the device's water reservoir regularly, let the heater plate and water tank cool for at least 15 minutes before removing the tank and check the device for unusual smells before each use, the FDA said.
Consumers should immediately stop using the DreamStation 2 if you they smell burning or see smoke, hear unusual sounds coming from the machine or if water has spilled onto the machine, the FDA added.
Philips said in a statement Wednesday that it has reviewed complaints about the DreamStation 2 sent to the FDA.
"The devices can continue to be used provided that the safety instructions for use for the DreamStation 2 sleep therapy device are followed," the company said.
Philips recalled more than 5 million other CPAP machines in 2021 because pieces of a polyester-based polyurethane (PE-PUR) foam inside the units were breaking off and blowing into users' mouths, potentially causing serious injuries. Since the recall, the FDA said it has received 105,000 complaints, including 385 reports of deaths, allegedly linked to the foam breakdown. The foam is purposely placed in Philips CPAP machines to help reduce noise.
The 2021 recall was for 20 different Philips devices, including its A-Series BiPAP ventilators and the DreamStation 1 CPAP machine. The company tried to fix some of the machines, but previously repaired devices have also been recalled, according to the FDA.
The agency says it does not believe the safety issue with the DreamStation 2 is related to the PE-PUR foam.
Nevertheless,ozens of sleep apnea patients in recent years have filed lawsuits against Philips related to the CPAP machines. In many of the lawsuits, Philips customers accused the company of continuing to sell the CPAP machines even after they knew the devices were defective. Those lawsuits were consolidated in October 2022 into one class-action case in Pennsylvania.
About 30 million people in the U.S. suffer from sleep apnea, a disorder in which someone's airways become blocked during rest and interrupts breathing, according to 2022 data from the American Medical Association.
Philips in September agreed to pay nearly $500 million to compensate customers who bought the devices, while admitting no wrongdoing.
