The agency received over 270 reports of thermal problems associated with these devices in the past three months, indicating a significant increase compared to the previous three years. Some of these devices were replacements for Dream Station 1 machines, which were recalled due to health risks linked to soundproofing foam.
The FDA suspects the issue may be related to electrical or mechanical malfunctions causing overheating in specific situations. Philips, in response, reported that the 270 complaints cover a three-year period and are currently in discussions with the FDA. The company emphasized that the DreamStation 2 uses a different type of foam than the recalled devices in 2021, and the FDA does not believe the current overheating problems are foam-related based on existing evidence.
Medical device manufacturers are required to report malfunctions that could cause serious injury or death within 30 days to the FDA. Philips has not disclosed the number of injuries reported. The FDA recommends users inspect their Dream Station 2 devices for unusual smells or changes in appearance before and after each use. While Philips insists the devices are safe to use when following safety instructions, ongoing discussions with the FDA aim to develop mitigation strategies for the reported safety issues. The FDA reassures the public that addressing safety concerns related to CPAP machines remains a top priority.