The FDA decision follows the receipt of over 270 reports citing thermal issues such as fire, smoke, burns, and other signs of overheating while operating the machine. Image Credit: JHVEPhoto / Shutterstock.

The US Food and Drug Administration (FDA) has issued a safety warning regarding the risk of overheating for the Philips Respironics’ DreamStation 2 continuous positive airway pressure (CPAP) machines.

Some of the DreamStation 2 CPAP machines were distributed as replacements for recalled DreamStation 1 CPAP machines. In 2021, Philips recalled multiple ventilators, bilevel positive airway pressure and CPAP machines due to health risks. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration. The PE-PUR foam broke down in hot and humid conditions to release toxic chemicals including formaldehyde, a known carcinogen and respiratory irritant. These could then be breathed in or swallowed by the person using the device.

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This had been a point of contention as it has been alleged that Philips knew about the defects which had resulted in multiple deaths, as per a ProPublica report. The FDA added that the DreamStation 2 CPAP machines overheating issues were not related to the foam used in the machine, as per a 28 November press release. The agency believes that the issues may be due to an “electrical or a mechanical malfunction of the machine” causing it to overheat in certain conditions.

The FDA decision follows the receipt of over 270 reports citing thermal issues such as fire, smoke, burns, and other signs of overheating while operating the machine. As per the FDA, these medical device reports were received between 1 August and 15 November. Since the device’s approval on 10 July 2020, the agency had received fewer than 30 reports regarding the device, till 1 August.

The FDA has advised users to follow the product’s user manual and to report any concerns including “unusual smells, sounds, or changes in appearance” to both the agency and the manufacturer, Philips. The FDA also added that it is closely monitoring Philips’ handling of the June 2021 recall.

“The FDA is committed to assuring this new safety issue is resolved expeditiously. We will continue to monitor the company’s handling of this, among other safety issues, to ensure they take appropriate steps to mitigate the risk to patients,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

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“We share the public’s concerns regarding the new and continued safety issues of CPAP machines and certain recalled medical devices manufactured by Philips. Addressing these safety concerns remains a top priority for the FDA.”

Recently, Philips launched a set of artificial intelligence (AI) enabled solutions including EPIQ Elite 10.0 and Philips Affiniti ultrasound systems, BlueSeal MR Mobile system and the Philips HealthSuite Imaging PACS solution.