Certain Philips DreamStation 2 CPAP Machines May Overheat, FDA Warns
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Philips DreamStation 2 CPAP Users Urged To Use Caution
Recent medical device reports, or MDRs, received by the U.S. Food and Drug Administration have included fire, smoke, burns and other indications of overheating during use of the Philips CPAP machines.
FDA regulators noted an alarming increase in the number of MDRs linked to thermal problems. Between Aug. 1 and Nov. 15, there were more than 270 reports filed with the agency, a significant increase from the less than 30 MDRs recorded in the previous three years.
Philips issued a separate statement suggesting that it filed the reports with the FDA as part of a “retrospective review.”
“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,” according to the Netherlands-based company.
Philips maintains that the devices are safe to use in accordance with the safety instructions provided by the manufacturer.
Is This Linked to Previous Recalls?
Certain DreamStation 2 CPAP machines were distributed as replacements for the recalled DreamStation 1 CPAP machines.
Millions of Philips CPAP machines were recalled worldwide after polyester-based polyurethane sound abatement foam insulation degraded, sending toxic fumes and particles into users’ mouths and airways.
FDA officials said they do not believe the DreamStation 2 issue is connected to the foam.
“Based on the currently available evidence, the agency does not believe the safety issue with the DreamStation 2 is related to the foam used in the machine,” the FDA reported in a late November safety communication.
“This is a developing situation, and to date, reports gathered and analyzed by the FDA indicate that the thermal issues reported for the DreamStation 2 CPAP machines may be related to an electrical or a mechanical malfunction of the machine, which may cause it to overheat in certain situations.”
Recommendations for Device Users
The Philips DreamStation 2 machine is used to treat obstructive sleep apnea patients who fail to breathe while they sleep.
The device uses Continuous Positive Airway Pressure along with an internal humidifier and optional heated tubing to deliver humidification and added comfort during therapy, according to the device’s user manual.
The FDA recommends taking the following measures 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 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. Anyone who encounters a problem with a Philips CPAP machine should report it to the FDA via its MedWatch Voluntary Reporting Form.
DreamStation Plagued by Problems for Years
In 2021 and 2022, Philips Respironics recalled and later replaced certain CPAP, BiPAP and ventilator machines because of degradation in the machine’s PE-PUR foam.
The FDA later issued a Class I recall for many of the replacements related to faulty programming. Philips claims to have sent out over 2.4 million replacement devices and repair kits.
Nearly 750 Philips CPAP lawsuits are pending in multidistrict litigation over injury claims related to the recalled Philips CPAP machines.
A person who was injured or died because of Philips CPAP use may be entitled to damages. Lawyers are actively taking new cases.
