FDA warns: Philips sleep apnea machines at risk of overheating

Philips Respironics' DreamStation 2 device may have an electrical or mechanical problem that causes it to smoke or burn, regulators said.

FDA warns: Philips sleep apnea machines at risk of overheating
entertainment
29 Nov 2023, 06:49 PM
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Philips Respironics Device Warning

Device Warning: Philips Respironics Sleep Apnea Treatment

A device manufactured by Philips Respironics for the treatment of sleep apnea requires careful monitoring during use due to the risk of overheating, according to federal regulators.

The Food and Drug Administration (FDA) has issued a safety communication advising users to be vigilant.

To minimize the chances of the DreamStation 2 overheating, users are advised to regularly clean the device, place it on a flat surface, and keep it away from flammable materials while in use. The FDA also recommends unplugging the machine when not in use.

In response to the FDA's notification, Philips has released a statement stating that they have reviewed the complaints regarding the DreamStation 2 that were reported to the FDA.

"The devices can continue to be used as long as the safety instructions for the DreamStation 2 sleep therapy device are followed," the company assured.

Philips has issued a recall for over 5 million CPAP machines due to a potential safety hazard. The foam inside the machines, which is designed to reduce noise, has been found to break off and enter users' mouths, posing a risk of serious injury. The recall affects 20 different Philips devices, including the A-Series BiPAP ventilators and the DreamStation CPAP machines. Despite attempts to fix the issue, the repaired machines have also been recalled, according to the FDA. Philips has agreed to pay nearly $500 million in compensation to customers who purchased the affected devices, although the company has not admitted any wrongdoing.