The U.S. Food and Drug Administration (FDA) has recently issued an alert for patients and healthcare providers regarding a safety issue involving the DreamStation 2 Continuous Positive Airway Pressure (CPAP) machines by Philips Respironics. The device, used for treating obstructive sleep apnea, has reported thermal issues which resulted in some patient injuries.
The FDA’s safety communication was prompted by reports of fire, smoke, burns, and other signs of overheating while using the machine, as submitted through their medical device reports (MDRs). A significant increase in MDRs associated with thermal issues of the machine was noted between August 1, 2023, and November 15, 2023, totaling over 270 reports. Prior to August 1, 2023, fewer than 30 MDRs of similar nature were received since the device was cleared for marketing on July 10, 2020.
In response to these reports, the FDA is closely working with Philips Respironics to discuss mitigation strategies for this safety issue. Meanwhile, the agency advises users of the machine to follow the manufacturer’s instructions provided in the user manual and to inspect the machine for unusual smells or changes in appearance before and after each use.
This safety issue emerges as the FDA continues to monitor Philips’ handling of a June 2021 recall impacting millions of sleep therapy and respirator machines, including CPAP machines. The recall was due to the potential risks posed by the polyester-based polyurethane (PE-PUR) foam used in these machines, which could break down and potentially be breathed in or swallowed by the user. Notably, the DreamStation 2 machines utilize a silicone-based foam, not PE-PUR foam, and were not included in the June 2021 recall. However, some of these machines were distributed as replacements for users whose machines were affected by the recall.
Based on the currently available evidence, the FDA does not believe the safety issue with the DreamStation 2 is related to the foam used in the machine. Instead, the agency’s preliminary analysis suggests that the thermal issues may be due to an electrical or mechanical malfunction of the machine, causing it to overheat in certain situations. The FDA stated that it is working closely with Philips Respironics to fully understand the issue and will update the public accordingly.
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