Philips CPAP Recall Replacement & Repair Program Details

Harvey Kirk

By Harvey Kirk
Posted October 22, 2021

ADD YOUR COMMENTS

Months after a massive Philips Respironics DreamStation CPAP recall was issued, impacting millions of sleep apnea machines used by Americans every night, very little information or details have been provided about the proposed Philips CPAP recall replacement and repair program.

Contact Our Lawyers About Your Recalled Philips CPAP Machine

  • This field is for validation purposes and should be left unchanged.

Saiontz & Kirk, PA, Attorneys & Lawyers, Baltimore, MD

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. The 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.

More than 80% of all registered devices subject to the recall are part of the first-generation of Philips DreamStation sleep apnea machines. On September 1, the manufacturer announced vague plans for a Philips CPAP repair and replacement program for these products, indicating that it may take up to a year to complete. However, there remain more questions than answers about the safety of these proposed CPAP foam repairs, and how owners should go about replacing Philips DreamStation 1 machines with newer versions that supposedly do not experience the same problems.

A series of FDA answers to Philips CPAP frequently asked questions have also been issued, but little practical advise is provided for owners who have been put in a position of needing to buy a new CPAP machine and deciding whether to trust Philips Respironics to repair the foam inside their recalled DreamStation CPAP.

Saiontz & Kirk, P.A. currently represents individuals throughout the United States who are now pursuing a Philips CPAP recall lawsuit and settlement, after suffering side effects or injuries that may have resulted from breathing the toxic sound abatement foam particles.

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.

Philips DreamStation CPAP Recall Repairs

Philips Respironics announced in September 2021 that it anticipates “reworking” recalled DreamStation 1 CPAP machines, and hopes to complete the DreamStation repair and replacement program in about 12 months. However, no details have been provided about how it will remove and replace CPAP foam, and the process has not been independently verified to confirm that it will be safe for individuals to use these repaired DreamStation CPAP machines for sleep apnea therapy.

Can Philips CPAP sleep apnea machines 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.

It appears that the Philips CPAP sleep apnea machine repairs will involve removing the existing foam from the interior of the device, but the manufacturer does not provide any information about how it will “rework” the machines or how this process will 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 recall 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 machines are eligible for Philips CPAP recall repairs?

As of September 10, the FDA indicates that it has reviewed the proposed plan for Philips CPAP recall 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, this will likely impact more than 1 million devices sold throughout the United States.

Is it safe to replace Philips CPAP sound abatement foam?

That is the big question, and consumers are rightfully skeptical about the ability of the manufacturer to safely replace Philips CPAP sound abatement 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 raises questions about whether attempts to conduct recall repairs instead of replacing Philips DreamStation 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 attempt to remove Philips CPAP foam from their DreamStation machine themselves. Health officials have strongly warned against attempting any CPAP foam removal, as this may compromise the safety of the sleep apnea machine and actually introduce additional foam debris.

Attempting to remove DreamStation sound abatement 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 are 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
  • Kidney Disease
  • Liver Disease
  • Heart Attack
  • Heart Failure
  • Stroke
  • Respiratory Failure
  • Pulmonary Fibrosis
  • Auto-Immune Disorders
  • Pneumonia
  • Chronic Bronchitis
  • Chronic Asthma
  • Sarcoidosis
  • Pneumoconiosis
  • Hypersensitivity
  • Wrongful Death

If you or a loved one experienced injuries after using a recalled Philips Respironic 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.

No Comments • Add Your Comments

Add Your Comments

  • Have Your Comments Reviewed by a Lawyer

    Provide contact information below and additional private comments if you want an attorney to contact you to review a potential case.

    The information below will not be published to this page.

  • NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

  • This field is for validation purposes and should be left unchanged.