Philips Dreamstation 2 CPAP Fires and Overheating Problems Have Been Reported By Hundreds of Users

FDA warns DreamStation 2 devices that replaced millions of previously recalled Philips CPAP machines may be prone to overheating and catching on fire.

Following a recall issued for millions of Philips CPAP and BiPAP machines in 2021, over a risk that toxic sound abatement foam inside the devices may break down and cause users to develop cancer, respiratory illnesses and other ailments, officials are now warning the Philips DreamStation 2 replacement machines may pose a risk of overheating and catching on fire.

The U.S. Food and Drug Administration (FDA) released a Safety Communication on November 28, after determining that there have been roughly 300 medical device reports (MDRs) involving the DreamStation 2 CPAP overheating problems, including fires, smoking devices and burns suffered by users of the devices.

Officials warn there has been a sharp increase in the number of DreamStation 2 devices overheating resulting in burn injuries to customers over the last four months, and that an investigation has been opened with the manufacturer to determine the root cause of the problems.

Philips DreamStation CPAP Recall

The Philips DreamStation 2 was introduced at the same time the manufacturer issued a massive CPAP machine recall in mid-2021, which impacted millions of sleep apnea devices sold since 2009, due to the use of a defective polyester-based polyurethane (PE-PUR) foam that was intended to cut down on noise as the machines were used.

However, at the time of the recall, the manufacturer acknowledged the foam was prone to degrade and breakdown, releasing small black particles, chemicals and toxic gasses directly into the machine’s air pathways. Due to the serious health issues from breathing the Philips DreamStation 1 foam, consumers were told to immediately stop using their machines unless needed for life supporting treatment.

More than two years after the recall, there are now thousands of Philips CPAP lawsuits being pursued by former users, each involving allegations that regular users of the machines developed various forms of cancer, respiratory illnesses, lung diseases and other complications after exposure to the foam particles.

FDA Warning Over Philips DreamStation 2 Overheating & Fire Risks

As the FDA continues to closely monitor more than 105,000 medical device reports involving Philips CPAP, BiPAP and ventilator devices that were subject to the recall, many of which have been linked to side effects caused by the PE-PUR foam, the agency is now warning about new overheating problems with the DreamStation 2 device.

According to the release, prior to August 1, 2023, the FDA was aware of 30 MDRs associated with DreamStation 2 thermal issues. However, officials now indicate they have received a sharp increase of an additional 270 thermal events involving DreamStation 2 devices between August 1, 2023 and November 15, 2023, which may be related to an electrical and/or a mechanical malfunction of the machine.

“Of note, the DreamStation 2 machines are manufactured with a silicone-based foam, not PE-PUR foam, and were not included in the June 2021 recall. However, consumers should be aware that some of these machines were distributed as replacement machines for some users whose machines were affected by the June 2021 recall”, the FDA stated in the warning.

While officials do not believe the new silicone-based foam is the source of the overheating issue, officials indicate that the investigation is still ongoing and for users to carefully monitor the devices for any signs of overheating.

Lawsuits Claim Philips Delayed Toxic Foam Recall

According to allegations raised in a mounting number of Philips CPAP lawsuits now being pursued throughout the U.S. Court system, the manufacturer delayed issuing a recall or warning consumers about health risks caused by the toxic foam until after it had finished developing the DreamStation 2 CPAP machines, and had them available to sell to individuals who rely on sleep apnea machines.

In a recent FDA investigation into the extensive history of consumer complaints to the manufacturer, the FDA revealed that Philips sat on more than 220,000 consumer complaints prior to the recall, including adverse events that contained keywords like contaminant, particles, foam, debris, and other clear signs there was a recurring problem with the sound abatement foam.

In a recently published ProPublica investigation, Philips appears to have intentionally concealed problems with the CPAP machines from the U.S. Food and Drug Administration (FDA), and that the company’s own scientists had confirmed there was a health risk for users several years before the recall was finally issued.

As a result of the findings, Senator Richard Blumenthal, of Connecticut sent a letter to the FDA’s Administrator Robert Califf, and Attorney General Merrick Garland at the Department of Justice (DOJ) calling for “immediate action”, suggesting that criminal charges should be brought against Philips, if the findings are substantiated.

November 2023 Philips DreamStation Lawsuit Update

In September, Philips announced it will pay a minimum of $445 million in a CPAP recall class action settlement to individuals who bought, rented or leased one of the impacted devices, and another $34 million to health insurance companies and others who paid to reimburse users to replace the machines.

However, the Philips CPAP class action settlement does not address the thousands of personal injury lawsuits brought over side effects of CPAP foam exposure, which has been linked to reports of cancer, leukemia, lymphoma, pulmonary fibrosis, interstitial lung disease, sarcoidosis and other disease.

Given common questions of fact and law raised in Philips CPAP lawsuits filed throughout the federal court system, all cases have been centralized before Senior U.S. District Judge Joy Flowers Conti in the Western District of Pennsylvania for coordinated discovery and pretrial proceedings, as part of a multidistrict litigation (MDL).

In an updated November 2023 JPML MDL Pending Docket Report, the panel reported there were currently 742 Philips CPAP lawsuits currently pending in the MDL, however, this does not include thousands of additional cases that remain unfiled because the plaintiffs have entered into a tolling agreement with Philips.

Throughout the rest of 2023 and into 2024, the number of claims is expected to continue growing, both involving injuries diagnosed long before the recall, as well as new injuries that continue to be diagnosed months after users breathed the toxic particles released as the sound abatement foam degraded inside their machines.