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What Are Philips CPAP and BiPAP Devices Used For?

“A continuous positive airway pressure (CPAP) machine is the most commonly prescribed device for treating sleep apnea disorders.” (1) Basically, these devices send a steady flow of oxygen into your mouth and nose while you are sleeping. The devices keep your airways open and help you breathe.

A CPAP machine uses a compressor, or motor. This motor generates a steady stream of pressurized air. The air moves through an air filter into a flexible tube. This tube allows purified air to move into a mask you wear. The mask is sealed around your nose and/or mouth. (2)

Ideally, you experience uninterrupted sleep. Because the air from this device is pressurized, it pushes against any blockages. Your airways remain open and your lungs receive oxygen. (3)

Types of Breathing Machines

In addition to CPAP devices, other breathing machines include APAP and BiPAP devices. All are intended to help you breathe normally while you are sleeping. Here is a breakdown of these devices: (4)

  • CPAP – This breathing device is programmed to generate pressurized air at one constant air pressure level. If you want to change the air pressure setting, you need to reset the device.
  • APAP – This automatic positive airflow pressure machine monitors how you breathe throughout the night. It adjusts the air pressure automatically if you change position while you are sleeping. This device also compensates for medications you are taking that may have changed how you breathe.
  • BiPAP – A bi-level positive airflow pressure device comes with two pressure settings. One uses pressure for inhaling. A second uses a lower pressure for exhaling. BiPAP devices can come with a backup respiratory rate to help patients with central sleep apnea. The backup makes sure you breathe. This device works better if you cannot tolerate CPAP machines, or have higher levels of carbon dioxide in your blood.

Foam Inhalation Can Cause Serious Injury or Death

According to the U.S. Food & Drug Administration (FDA), “The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.” (5)

On November 12, 2021, the FDA provided an update on the recall. The FDA had inspected a Philips facility “to determine what may have caused or contributed to the foam issues and to assess adherence to the agency’s quality system regulations.” (6)

During the inspection, the FDA learned that Philips’ replacement foam, which is silicone-based, may contain volatile organic compounds (VOCs). The FDA requested an independent laboratory test the foam for any potential safety risks.

Additionally, the FDA inspection revealed that Philips was aware no later than 2015 that the polyester-based polyurethane foam (PE-PUR) foam that is the subject of the recall had a degradation issue that was dangerous to users. Internal company testing also revealed the toxicity and potential carcinogenicity of the PE-PUR foam degradation products, yet Philips chose to keep using the PE-PUR foam over safer alternatives. (7)

Philips Respironics, the manufacturer, used PE-PUR foam to lessen the sound and vibration of its breathing devices. However, if this foam comes into contact with your airways or digestive tract, dangerous side effects or medical complications may occur: (8)

  • If the foam breaks down, you may inhale or swallow foam particles.
  • Foam particles may release toxic chemicals, which you can breathe in or ingest.

Inhaling or swallowing PE-PUR foam particles can lead to serious injury. Possible injuries can be life-threatening. Injuries may also be permanent. Medical treatment may be necessary to prevent irreversible damage. (9)

Complaints and Dangerous Side Effects

Philips has received complaints from patients. Some patients have noted black debris, or particles, in their breathing device’s air pathway. Patients have reported headaches, irritation in their upper airway, chest pressure, a cough, and sinus infections. These side effects may be linked to inhalation of foam particles. (10)

If you have inhaled or swallowed PE-PUR foam particles, you may experience a variety of side effects and complications, including: (11)

  • Headache
  • Dizziness
  • Irritation of the eyes, nose, respiratory tract, or skin
  • An inflammatory response
  • Hypersensitivity
  • Nausea and vomiting
  • Toxic and carcinogenic effects to your internal organs

Potential Life-Threatening Health Complications

Long-term, permanent, and life-threatening health complications – including cancer – of PE-PUR foam are possible. If you are diagnosed with any of these conditions, your illness may be linked to your use of Philips CPAP and BiPAP:

  • Acute Respiratory Distress Syndrome (ARDS)
  • Reactive Airway Disease
  • Respiratory failure
  • Recurrent pneumonia (pneumonitis)
  • Pleural effusion
  • Lung/Pulmonary disease
  • Lung/Pulmonary damage
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Asthma
  • Sarcoidosis
  • Chemical poisoning

Breathing Machines May Cause Cancer

Another serious concern is the possibility of developing different types of cancer. These cancers include:

  • Lung
  • Thyroid
  • Lymphatic
  • Leukemia
  • Nasal
  • Lymphomas
  • Multiple myeloma
  • Oral, including palate and tonsils

Philips Recalls Breathing Devices

On June 30, 2021, the FDA alerted the public that Philips recalled certain devices due to concerns regarding its polyester-based polyurethane sound abatement foam. (12) The FDA has recognized this as a Class I recall, “the most serious type of recall. Use of these devices may cause serious injuries or death.” (13)

“The off-gassed chemicals and foam particles may lead to serious or life-threatening injuries, difficulty breathing (respiratory distress), swelling (inflammation), a lack of oxygen (hypoxia), too much carbon dioxide (hypercarbia), or toxic reactions.” (14)

As of May 2, 2022, the FDA reported it has not received all the chemical risk information requested from Philips. However, the company has posted a clinical information update for doctors. (15)

On that same date, a proposal was issued by the FDA’s Center for Devices and Radiological Health (CDRH). It requests Philips submit “a plan for the repair, replacement, or refund of the purchase price of the recalled devices manufactured after November 2015.” The CDRH is also “Continuing to encourage Philips Respironics to have a consistent and transparent approach for repairing or replacing the impacted devices.” (16)

There have been more than 48,000 complaints, including 44 deaths, reported as of July 22, 2021. All serial numbers of these types of devices and models have been recalled: (17) (18) (19)

Recalled CPAP and BiPAP Devices

  • Continuous ventilator, minimum ventilatory support, facility use – E30.
  • Continuous ventilator, non-life supporting – DreamStation ASV; DreamStation ST, AVAPS; SystemOne ASV4; C-Series ASV; C-Series S/T and AVAPS; OmniLab Advanced+.
  • Noncontinuous ventilator – SystemOne (Q-Series); DreamStation; DreamStation Go; Dorma 400; Dorma 500; REMstar SE Auto.

Recalled Ventilators

  • Continuous ventilator – Trilogy 100; Trilogy 200; Garbin Plus, Aeris, LifeVent.
  • Continuous ventilator, minimum ventilatory support, facility use – A-Series BiPAP Hybrid A30 (not marketed in U.S.); A-Series BiPAP V30 Auto.
  • Continuous ventilator, non-life supporting – A-Series BiPAP A40; A-Series BiPAP A30.

Additional models were recalled in December 2021 by Philips and announced by the FDA on January 26. According to the FDA, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators with specific serial numbers. The foam was determined to be PE-PUR foam, the same foam used in Philips Respironics devices previously recalled in June 2021. (20)

These additional recalled items were manufactured and distributed between April 15 and May 24, 2021:

  • Trilogy Evo ventilator. (21)
  • Repair kits for the Trilogy Evo muffler assembly. (22)

If you or a loved one suffered serious medical complications or a health injury after using a recalled Philips medical device, you may be entitled to compensation. Compensation may cover medical expenses, as well as your pain and suffering, loss of earnings, and potential future income loss. Punitive damages may also be awarded.

Possible compensation you could receive includes:

  • Costs due to doctor visits.
  • Medication reimbursement.
  • Nursing and other related care costs
  • Money for days you were not able to work due to your injury.
  • Money for future income you cannot make if your injury does not allow you to work.

How W&L Can Help

As an experienced, national law firm, Weitz & Luxenberg has made it our mission to stand up to medical device manufacturers who sell faulty products that harm people. These breathing devices fall into that category.

Our attorneys have a successful track record of winning billions of dollars in settlements and verdicts for our clients. Here are a couple examples of our victories for our clients that were led by Ellen Relkin, partner and chair of Weitz & Luxenberg’s Drug and Medical Device Litigation practice group:

  • $1 Billion+ – Weitz & Luxenberg helped secure this settlement with Stryker on behalf of thousands of patients injured by the company’s Rejuvenate and ABGII modular hip implants.
  • $2.5 Billion – Weitz & Luxenberg played a key role in helping achieve this settlement with DePuy on behalf of thousands of patients injured by the company’s ASR hip replacement implants.

Our team of knowledgeable medical device attorneys is prepared to help you. In fact, Brendan McDonough is not only a medical device attorney on the team, but he is also a medical engineer.

“I’m proud to be able to use my engineering skills to further the legal case against defective medical devices that harm our clients,” emphasizes Mr. McDonough. “When manufacturers create devices that cause injury, they deserve to be held accountable.”

W&L Takes the Lead

Weitz & Luxenberg is helping lead the charge against Philips Respironics for their defective CPAP devices. Mr. McDonough was selected to speak about the dangers associated with the toxic and carcinogenic compounds released by these devices at Mass Torts Made Perfect and the HarrisMartin Webinar Series: Philips CPAP, BiPAP & Ventilator Litigation in September 2021.

Our law firm is offering you a free consultation. Contact us so we can help you explore your legal options.