Philips CPAP Machine Repair Program & Foam Removal Risks

By Harvey Kirk
Posted October 22, 2021

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Updated April 13, 2023: There have been unacceptable delays in the Philips CPAP repair and replacement program since this blog was posted, and it is taking the manufacturer substantially longer than any consumer reasonably could have anticipated. This week, the FDA issued an update on the status of CPAP repairs, indicating that Philips has actually shipped far fewer replacement CPAP machines than it claims. Philips has indicated on it’s website that that 2,460,000 “new replacement devices and repair kits” have been shipped, but this number misleadingly includes kits shipped internally to repair facilities, which have not yet been used to actually fix recalled Philips Dreamstation, CPAP and BiPAP machines.

Updated March 21, 2022: Nearly one year after a massive Philips CPAP machine recall was issued, which impacted millions of DreamStation and other sleep apnea machines, very little information has been provided about proposed CPAP machine repairs and whether the devices will be safe to use after the toxic CPAP foam is removed. This post has been updated to include information and concerns about the safety of repaired Philips machines.

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Since June 2021, owners of the recalled sleep apnea machines have been urged to immediately stop using their device unless it is providing life-sustaining therapy, since defective PE-PUR sound abatement foam inside the devices may deteriorate and degrade, releasing black particles and toxic chemicals directly into the machine’s air pathways.

There is increasing evidence that indicates Philip CPAP foam side effects may cause users to suffer a variety of serious and potentially life-threatening injuries, ranging from cancer to permanent lung damage.

Plans for a Philips CPAP machine repair and replacement program were first announced by the manufacturer in September 2021, indicating that it anticipated fixing recalled CPAP and BiPAP machines would take a year. However, it has taken substantially longer and serious questions have emerged about the safety of repaired machines.

In March 2022, the FDA sent a warning letter (PDF) to Philips, indicating that the company was not doing enough to make sure consumers were aware of the risks associated with the recalled CPAP machines and steps they can take to obtain a replacement machine. The agency then indicated in April 2017 that certain repaired DreamStation CPAP, BiPAP machines may actually deliver inaccurate or insufficient therapy, resulting in a new Class I recall for these devices.

Although a series of Philips CPAP frequently asked questions have been provided by the FDA, there still remain few answers about the long-term risks users face and the safety the proposed CPAP foam repairs, or how owners should go about replacing Philips DreamStation 1 machines with newer versions that supposedly do not experience the same problems.

Saiontz & Kirk, P.A. currently represents individuals throughout the United States who are now pursuing a Philips CPAP lawsuit and settlement, after suffering side effects or injuries that may have resulted from breathing the toxic sound abatement foam particles. This post is designed to provide additional information in response to questions our Philips CPAP lawyers receive every day about the recall.

Our product liability lawyers strongly urge all owners of Philips DreamStation products to preserve their machine if they are considering a lawsuit, and request a free consultation and case evaluation before returning your CPAP machine for any Philips repair or replacement.

Recalled Philips CPAP Repair Options

Philips Respironics initially indicated that it will be “reworking” recalled DreamStation 1 CPAP machines, and suggested that it would complete the DreamStation repair and replacement program in about 12 months. However, they have failed miserably in this goal. In addition, limited information has been provided about the CPAP foam removal process, and it has not been independently verified that it will be safe for individuals to use these repaired DreamStation CPAP machines for sleep apnea therapy.

Can my Philips CPAP machine be repaired?

According to a statement released by Philips Respironics on September 1, 2021:

Philips received authorization from the U.S. Food and Drug Administration (FDA) for the rework of the affected first-generation DreamStation devices, which consists of replacement of the PE-PUR sound abatement foam with a new material.

The Philips CPAP machine repairs involve removing foam inside of the device. However, the manufacturer has not provided any information about how it will “rework” the machines and prevent the new sound abatement material from releasing black foam particles or chemicals that may enter the air pathways, tubing and face mask.

Until any Philips DreamStation repairs are independently evaluated and confirmed by health experts as safe and effective, our lawyers do not recommend that owners participate in this Philips CPAP “Reworking” program.

Which recalled machines are eligible for Philips CPAP repairs?

As of September 10, the FDA indicates that it has reviewed the proposed plan for Philips CPAP machine repairs on certain devices, including:

• Philips DreamStation CPAP; Pro, Auto (All Configurations)
• Philips DreamStation BiPAP; Pro, Auto (All Configurations)
• Philips DreamStation ST, ASV, AVAPS (All Configurations)

Philips has not yet provided any information about any plans for repairing other recalled CPAP, BiPAP and mechanical ventilators, including Trilogy ventilators, A-series BiPAP machines, C-Series BiPAP machines, OmniLab Advanced+, Garbin Plus, Aeris, LifeVen, E30 ventilator, REMstar SE Auto and E30 devices.

However, with more than 80% of all recalled CPAP machines coming from the first-generation DreamStation sleep apnea family of products, any Philips repair program will impact millions of devices sold throughout the United States.

Is Philips CPAP foam removal and replacement safe?

That is the big question, and consumers are rightfully skeptical about the ability of the manufacturer to safely remove Philips CPAP foam in a way that will not compromise the device or lead to additional future health risks after their repaired DreamStation 1 device is returned to them.

While the FDA initially “reviewed and concurred” with the Philips Respironics plan to replace PE-PUR sound abatement foam, little information has been publicly disclosed about this process and the safety has not been independently verified by plaintiffs’ lawyers or a court. The FDA decision to authorize the repairs was based only on a review of information provided by Philips Respironics.

In November 2021, the FDA issued an update on the Philips CPAP foam replacement, indicating that there may be concerns about the safety of the new silicone foam that is being used. A similar device marketed outside the United States with a silicone-based sound abatement foam failed safety tests for the release of certain chemical compounds that may pose serious health risks. Therefore, the FDA indicates that it has insufficient information to conclude whether the Philips DreamStation replacement silicone foam poses a risk to patients.

The lack of details provided by the manufacturer about the CPAP foam removal process raises questions about whether attempts to conduct DreamStation repairs instead of replacing the CPAP machines with new products is just another attempt by the manufacturer to minimize the costs associated with this massive recall.

Can I remove DreamStation sound abatement foam myself?

No. Owners should NOT attempt to remove Philips CPAP foam from their DreamStation machine themselves. Health officials have strongly warned against any individuals attempting CPAP foam removal, as this may compromise the safety of the sleep apnea machine and actually introduce additional foam debris.

Removing DreamStation foam yourself may also impact your ability to successfully pursue a lawsuit over any long-term side effects of Philips CPAP treatments that may be experienced after breathing the toxic chemicals and black particles directly into your lungs.

Any alteration or change to the CPAP machine may open the door for Philips Respironics to defend your future claim under the legal theory of “spoliation of evidence”. Therefore, the Philips CPAP recall lawyers at Saiontz & Kirk, P.A. are strongly urging all clients to preserve their recalled sleep apnea machine and not attempt any repairs yourself.

^^^ Index of Information About Philips CPAP Repairs vs. Replacements ^^^

Philips DreamStation 2 Replacements

Rather than attempting to have a Philips DreamStation 1 repaired, it is strongly recommended that a replacement CPAP machine be obtained. Unfortunately, inventory of new machines remain in limited supply and Philips Respironics has not offered to reimburse the cost of purchasing new sleep apnea machine replacements.

Several months before the recall was announced, a new-generation Philips DreamStation 2 machine was introduced, which the manufacturer now claims does not experience the same problems with foam deteriorating and degrading. However, many consumers do not want to reward Philips Respironics by purchasing their new DreamStation. Therefore, Philips CPAP machine alternatives sold by ResMed, DeVilbiss, Human Design Medical and other competitors have become top sellers.

Will Philips replace my CPAP machine?

When the Philips CPAP recall repairs were announced on September 1, the manufacturer did indicate that it is now beginning to provide DreamStation 2 CPAP replacement devices for some consumers. However, it is unclear who is eligible to receive this newer device.

There is no current program to get Philips to replace your recalled DreamStation CPAP machine. However, full compensation and reimbursement is being sought through Philips CPAP recall class action lawsuits moving through the court system.

Is Philips reimbursing the cost of replacing CPAP machines?

No, not at this time. While Philips should be offering free replacements immediately or reimbursing costs associated with buying a new sleep apnea machine, the company is currently refusing to do so. As a result, many consumers are being forced to go “out-of-pocket” to obtain a new CPAP machine to replace recalled DreamStation devices.

Among the damages being pursued through Philips CPAP recall lawsuits will be the costs of replacing DreamStation machines with safer alternatives.

What should I do with my recalled Philips CPAP machine after it is replaced?

If you plan to pursue a Philips CPAP settlement or lawsuit, the product liability lawyers at Saiontz & Kirk, P.A, are strongly urging all owners to preserve and save the recalled Philips sleep apnea machine without making any alterations or changes, as this device may provide important evidence in your case.

Make sure the CPAP machine is stored in a way that will avoid any damage, and clearly marked so that it is not used.

If you are forced to return the CPAP machine due to lease obligations or other requirements, make sure you take multiple photos of the device from all angles, including serial numbers or other identifying information.

For individuals who are not saving the machine, the FDA indicates that consumers should contact their health care provider to obtain information on your local Philips Respironics representative to receive instructions and directions for returning recalled CPAP machines. Do not discard or attempt to recycle the machine.

How Dangerous Are Unrepaired Philips CPAP Machines on Recall?

The Philips CPAP machine recall has been categorized by the FDA as a “Class 1” medical device recall, suggesting that continued use of the machines pose a serious risk of adverse side effects or death. This is the most serious type, and unrepaired Philips CPAP machines on recall should not be used unless necessary for life-sustaining therapy or under the specific direction of a medical provider.

The PE-PUR sound abatement foam in these machines may deteriorate and break down, releasing black particles, chemicals and gases directly into the tubing, face mask and lungs of users.

Several hazardous and cancer-causing materials have been identified in the Philips PE-PUR foam, and users have reported a wide variety of severe injuries after long-term exposure, including:

• Cancer, Lymphoma, Leukemia or Tumors
• Pulmonary Fibrosis
• Interstitial Lung Disease (ILD)
• Pulmonary Fibrosis
• Sarcoidosis
• Pneumoconiosis
• Auto-Immune Disorders
• Chronic Asthma
• Chronic Bronchitis
• Recurrent Pneumonia
• Hypersensitivity
• Kidney Disease
• Liver Disease
• Heart Attack
• Heart Failure
• Stroke
• Wrongful Death

If you or a loved one experienced injuries after using a recalled Philips Respironics CPAP machine, you have important legal rights. To find out whether settlement benefits and financial compensation may be available, request a free consultation and case evaluation.