Philips Repaired DreamStation CPAP, BiPAP Machines May Malfunction or Fail to Deliver Therapy

More than 1,000 supposedly repaired Philips DreamStation CPAP and BiPAP machines are being recalled once again, due to a mix-up with the serial numbers, which may cause the devices to fail to provide proper breathing assistance to users.

The U.S. Food and Drug Administration (FDA) announced the Philips DreamStation recall on April 7, indicating that the repaired CPAP and BiPAP machines may fail to deliver the correct prescription or default to factory settings. They may also may fail to deliver therapy entirely, posing serious risks for individuals who rely on the sleep apnea machines.

The recall came after Philips received 43 complaints of problems with repaired DreamStation CPAP and BiPAP machines. However, no injuries or deaths have been linked to the recall, according to the manufacturer.

According to the recall notice, the devices, which were previously subject to a major Philips CPAP recall in June 2021 and then reworked and sent back to consumers, may have been assigned incorrect or duplicate serial numbers during programming. This error may lead to the device using the wrong prescription settings, or defaulting to factory settings. In some cases they may fail to deliver therapy altogether.

The recall indicates there is no warning or indication the devices are not working as intended, and the failure to deliver therapy could result in respiratory failure, heart failure, serious injury or death. As a result, the FDA has given the recall as Class I designation, meaning the agency believes the problem could result in severe injury or death.

Philips CPAP, BiPAP Machine Recalls

Millions of recalled Philips CPAP, BiPAP and ventilator machines sold since 2009 were pulled from the market in June 2021, following widespread reports of small black particles from a polyester-based polyurethane (PE-PUR) being found in the tubing and face masks. Although the foam was intended to reduce noise and vibrations while the machines were used, the FDA warned that the PE-PUR foam may release a number of toxic chemicals and gases directly into the machine’s air pathways.

As a result of the potential CPAP foam health risks, federal health officials indicated all consumers should immediately stop using the recalled machines, unless needed for life-sustaining therapy, and a widespread Philips repair and replacement program was launched to remove the PE-PUR foam from machines and substitute a silicone-based foam. However, this latest Philips recall impacts certain previously repaired ventilators.

The new recall comes as the manufacturer already faces a growing number of Philips CPAP lawsuits brought by former users of recalled machines, who have been diagnosed with certain types of cancer, lung damage and other side effects from the small foam particles entering their mouth and lungs.

Philips Repaired DreamStation Breathing Machine Recall

The recall affects 1,099 Philips Respironics DreamStation 1 (Uno Remediated Devices), including the REP DreamStation Auto CPAP Recert, DreamStation Auto, FR REP DreamStation Auto BiPAP, DOM-RECRT, and REP DreamStation Auto CPAP, DOM – RECRT product models. The reworked devices were distributed between December 1, 2021 and October 31, 2022.

The FDA indicates Philips sent affected customers an Important Product Notice in February, warning them of the problem and providing them with a list of serial numbers of potentially affected devices. The letter instructed users on how to locate the serial number on the bottom of the device and verify it against the serial numbers listed in the letter.

Philips is recommending patients continue using their current device until a replacement is received or until pressure changes are made by their health care providers on their current device. Philips also recommends they contact their provider about getting a manual reset of the device’s pressure either remotely or in person.

Philips indicates replacement products will be provided to customers in exchange for the affected devices. Patients with questions can contact their local Philips representative at 1-877-387-3311, or by email at patientsupport@philips.com. They can also visit the company’s website for patient information.

Philips CPAP Recall Repair Problems

Philips’ attempt to repair and rework the recalled CPAP, BiPAP and ventilator machines has been beset by problems. Philips first announced a CPAP machine repair and replacement program in September 2021, but the pace of repairs has been extremely slow and there have been some concerns about the safety of the alternative foam material the manufacturer is using, which may also release harmful chemicals directly into the machine’s air pathways.

The FDA has criticized Philips handling of the recall, accusing the company of not doing enough to warn consumers about the health risks associated with continuing to use recalled CPAP machines.

In February, the FDA announced a recall of nearly 14,000 repaired Philips Trilogy 100, Trilogy 200 and Garbin Plus ventilators due to problems with the replacement silicone foam, which may separate from its plastic backing due to failure of the adhesive used to hold it in place.

That same month, the FDA announced it has received nearly 100,00 medical device reports involving problems with Philips CPAP, BiPAP and ventilator devices, including reports of nearly 350 deaths.

April 2023 Philips CPAP Lawsuit Settlement Update

There are currently more than 300 lawsuits against Philips already filed in the federal court system, with thousands of additional CPAP injury claims registered on a census established by the court to toll the statute of limitations.

Given common questions of fact and law raised lawsuits filed throughout the federal court system, the Philips CPAP litigation has 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).

Throughout 2023, the number of claims is expected to rapidly grow, 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.

Negotiating Philips CPAP settlements for the injury claims will be more complex than the economic loss class action lawsuits, given the wide variety of different types of cancer and lung damage individual plaintiffs have alleged may be caused by the sleep apnea machines, including:

• Leukemia, Lymphoma or other Cancers
• Pulmonary Fibrosis, Sarcoidosis or other Lung Diseases
• Chronic Asthma, Bronchitis or Pneumonia
• Liver Injury, Kidney Injury, Heart Attack, Stroke or Heart Failure

As part of the coordinated management of the litigation, Judge Conti has also directed the parties to establish a bellwether process, where small groups of representative claims will be prepared for early trial dates if Philips CPAP settlements can not be reached to resolve large numbers of claims.

While the outcome of these early verdicts will not have any binding impact on other plaintiffs, the average Philips CPAP lawsuit payout amounts awarded by juries are likely to have a big influence on how much the manufacturer will pay to settle claims, to avoid each claim being remanded to different U.S. District Courts nationwide for separate trial dates in the future. However, a settlement agreement reached before then may make such trials unnecessary.