麻豆传媒

Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for sleep apnea may overheat, according to an on Tuesday urging patients to monitor their devices.

"The FDA recently received medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs of overheating" while patients are using the devices, the agency said. Between August 1 and November 15 of this year, the FDA received more than 270 MDRs for the DreamStation 2, a steep increase compared with the less than 30 MDRs received in the 3 years prior.

Users of the devices are instructed to unplug the device if they smell smoke, burning, or any other unusual odors, if they observe any changes to the CPAP device's appearance or performance, if water has been spilled on the device, or if any unusual sounds are heard coming from the device. FDA suggested that patients inspect devices for noticeable changes frequently, noting that some problems may not be seen until the device is in use, asking users to pay attention to any differences in the CPAP machine as they prepare for bed.

If patients do not experience any issues with their device, the FDA does not recommend discontinuing use.

Some of the devices were replacements for DreamStation 1 CPAP devices, which were recalled due to a breakdown of the polyester-based polyurethane foam used for soundproofing that posed potential carcinogenic and other health risks.

"Based on the currently available evidence, the agency does not believe the safety issue with the DreamStation 2 is related to the foam used in the machine," FDA stated, suggesting that the thermal issues "may be related to an electrical or a mechanical malfunction of the machine, which may cause it to overheat in certain situations."

Tuesday's announcement is the latest in a series of setbacks for Philips breathing devices. Beyond the foam-related recall, the company's CPAP and bilevel positive airway pressure (BiPAP) machines earlier this year were hit with a recall due to the potential that some devices may deliver incorrect levels of therapy or no therapy at all.

FDA encouraged DreamStation 2 users to adhere to user manual instructions. These include laying the device on a flat surface, away from any carpeted, fabric, or flammable areas, emptying the device's water reservoir, and carefully cleaning the device. Users should also allow for the heater plate and water tank on the device to cool down for approximately 15 minutes prior to removal, as a way to reduce the risk of burns.

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