FDA Safety Communication: Philips DreamStation 2 CPAP Machines

• By: Maureen Carland
• On: 12/12/2023 08:34:21
• In: Quality/Regulatory

The U.S. Food and Drug Administration (FDA) is issuing a cautionary notice to both patients and healthcare providers, urging them to exercise close monitoring of Philips DreamStation 2 continuous positive airway pressure (CPAP) devices for any indications of overheating.
In recent times, the FDA has received reports of medical device incidents (MDRs) linked to thermal problems, including instances of fire, smoke, burns, and other manifestations of overheating during the use of Philips DreamStation 2 CPAP devices. The agency has observed a notable surge in such reports concerning DreamStation 2 CPAP devices. Between August 1, 2023, and November 15, 2023, the FDA has accumulated over 270 reports detailing issues associated with these devices, a stark contrast to the less than 30 MDRs received in the preceding three years.
It is worth noting that some DreamStation 2 CPAP machines were distributed as replacements for recalled DreamStation 1 CPAP devices. Based on the available evidence at present, the FDA does not believe that the safety concern with the DreamStation 2 is linked to the foam used in the machine. This remains an evolving situation, and as of now, the reports collated and assessed by the FDA suggest that the thermal problems reported with DreamStation 2 CPAP devices may be attributed to either electrical or mechanical malfunctions of the machine, potentially causing overheating in specific scenarios.
Read full notice, including FDA recommendations here
 
Staff contact: mcarland@mehca.org