FDA Urges Vigilance in Monitoring Philips DreamStation 2 CPAP Machines for Overheating Risks

The U.S. Food and Drug Administration (FDA) has issued a safety communication urging patients and healthcare providers to carefully monitor Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating. The warning comes in response to an increase in medical device reports (MDRs) associated with thermal issues, including fire, smoke, burns, and indications of overheating during the use of these devices.

Incident Overview

Between August 1, 2023, and November 15, 2023, the FDA received over 270 reports of problems related to Philips DreamStation 2 CPAP machines, a significant increase compared to fewer than 30 MDRs over the previous three years. Notably, some DreamStation 2 CPAP machines were distributed as replacements for recalled DreamStation 1 CPAP machines.

Possible Causes and Current Understanding

While the investigation is ongoing, the FDA suggests that the thermal issues reported for the DreamStation 2 CPAP machines may be linked to an electrical or mechanical malfunction, potentially causing overheating in certain situations. At present, there is no indication that the safety issue is related to the foam used in the machine.

Recommendations for Patients, Caregivers, and Healthcare Providers

The FDA provides several recommendations for users of DreamStation 2 CPAP machines:

1. Follow the manufacturer’s instructions in the user manual, including proper placement on a firm, flat surface, keeping the device away from flammable materials, and regular cleaning.
2. Inspect the CPAP machine before and after each use for unusual smells or changes in appearance.
3. Unplug and refrain from using the CPAP machine if there are any signs of burning, smoke, unusual odors, changes in appearance, performance issues, or if water is spilled into the machine.
4. If unable to use the CPAP device due to safety concerns, consult with a healthcare provider.

Reporting Problems and FDA Actions

Users are encouraged to report any concerns about their CPAP machine to both the FDA and Philips. The FDA is actively working with the company to understand the underlying issues and is in discussions regarding mitigation strategies. Patients are advised not to discontinue use of the machines unless they are experiencing the specified issues.

Device Description

The Philips DreamStation 2 CPAP machine is designed to deliver positive airway pressure for the treatment of obstructive sleep apnea, and it is used in both home and clinical settings.

Contact Information for Concerns and Questions

For those with questions or concerns, the FDA recommends contacting the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or calling 800-638-2041 or 301-796-7100.

The FDA will continue to provide updates to the public as new information becomes available, emphasizing their commitment to addressing and resolving this safety issue promptly.

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