Philips CPAP users are being warned of potential fire and overheating risks associated with the beleaguered machines, according to the FDA.
The U.S. Food and Drug Administration reported it received more than 270 medical device reports, or MDRs, associated with thermal issues from people using the Philips DreamStation 2 CPAP machines between Aug. 1 and Nov. 15.
By comparison, the agency only received 30 such reports in the previous three years.
“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 Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
A day after the FDA issued the warning, Philips released a statement claiming it sent the reports to the FDA as part of a “retrospective review.”
“Philips Respironics is in discussions with the [FDA] regarding the reports it filed with the FDA related to possible thermal issues in the humidifier of the DreamStation 2 sleep therapy device while in use,” the statement said. “Philips Respironics filed these approximately 270 reports over the last three months which cover a three-year period following a retrospective review of possible thermal complaints related to DreamStation 2 since the launch of the product.”
The CPAP machine, Philips said, is safe provided that users follow the safety instructions in the DreamStation 2’s 68-page manual.
Reports of Fires, Burns
Millions of Philips CPAP, BiPAP and mechanical ventilator devices were part of a worldwide CPAP recall after polyester-based polyurethane sound abatement foam insulation degraded, sending toxic fumes and particles into users’ mouths and airways.
Broken-down foam could cause toxic exposure resulting in respiratory and carcinogenic effects. FDA officials said they do not believe the overheating issue is connected to the foam.
The recent MDRs included issues like fire, smoke, burns and other signs of overheating while using the machines, according to the FDA.
Current Philips CPAP Lawsuits
Symptoms include airway inflammation, chest pressure, cancer, coughing and difficulty breathing, among others.
The Philips CPAP lawsuits claim the devices were defective and the company did not adequately warn the users about the risk of serious injury.
More than 740 cases are pending in multidistrict litigation and could go to trial as early as 2024. Lawyers are actively taking cases.
Recommendations for DreamStation CPAP Users
The Philips DreamStation 2 machine is used to treat obstructive sleep apnea patients who fail to breathe while they sleep.
According to the manufacturer, the device utilizes Continuous Positive Airway Pressure, an internal humidifier and optional heated tubing to deliver humidification and added comfort during therapy.
The FDA recommends the following for safe usage:
- Place the CPAP machine on a firm, flat surface away from carpet, fabric or other flammable materials.
- Carefully clean the CPAP machine and empty the water reservoir.
- Allow the machine to cool for 15 minutes before removing the tank to avoid the risk of burns.
- Inspect the machine daily before and after use for unusual smells or changes. Some issues may only be noticed when the machine is running.
- Unplug the machine and stop using it if there is a burning odor, smoke or unusual odor; or if there is a change in the appearance or unexplained changes in performance; if water is spilled on the machine; or if it makes unusual sounds.
The FDA and Philips Respironics are working together to understand what is causing the thermal issues. The FDA encourages anyone who encounters a problem with a Philips CPAP machine to report it to them using the MedWatch Voluntary Reporting Form.