Philips sleep apnea machines can overheat, FDA warns
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 the Philips' DreamStation 2 can start to issues or even start burning while in use. The agency said it received 270 reports or 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 kee it away from flammable materials when in use, the FDA said. Consumers should unplug the machine when it is not in use.
Philips said in a statement Wednesday that the company has reviewed the 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 foam inside the units meant to reduce noise was breaking off and blowing into users' mouths, potentially causing serious injuries.
The 2021 recall was for 20 different Philips devices, including its A-Series BiPAP ventilators and the DreamStation CPAP machines. The company tried to fix some of the machines, but the repaired ones have also been recalled, according to the FDA.
Philips in September agreed to pay nearly $500 million to compensate customers who bought the devices, while admitting no wrongdoing.
