Philips Respironics CPAP Recall

Philips Respironics CPAP Machines

Chicago-Based Attorney for Philips Respironics CPAP Machines

Doctors use continuous positive airway pressure (CPAP) therapy to treat obstructive sleep apnea. With a CPAP machine, steady air pressure is delivered to a sleeping patient via a hose and mask or nosepiece. Issues that commonly come up in connection with the CPAP include leaky masks, trouble falling asleep, stuffy noses and dry mouths. However, in June 2021, the Food and Drug Administration announced a Class I recall of certain Philips Respironics CPAP and BiPAP ventilators. Class I recalls are the most serious types of recalls; they are issued when devices may cause serious injuries or death. If you or a loved one were diagnosed with cancer (throat, esophageal, lung, liver or kidney cancer) or other adverse medical effects due to a Philips Respironics CPAP or BiPAP machine, you should call the experienced Chicago-based lawyers of the Moll Law Group. Billions have been recovered in product liability lawsuits with which we’ve been involved.

Risk of Carcinogen Exposure in Philips Respironics Machines

Philips Respironics’ Continuous and Non-Continuous Ventilators are used to offer invasive and non-invasive support for those who seeking respiratory support or treatment for sleep disorders. As a patient with sleep apnea, your doctor may have prescribed a particular ventilator based on your therapeutic needs. CPAPs, BiPAPs, and ventilators can be used by patients in a range of different settings including both homes and health care practices or hospitals.

On June 14, 2021, the company sent an urgent recall letter about its CPAP and BiPAP machines. It asked patients to stop using the device and work with a doctor or Durable Medical Equipment (DME) provider to decide what the most appropriate options for continued treatment were. The recall letter also specified that customers and patients should stop using ozone-related cleaning products, which can worsen the breakdown of foam; this increases the risks associated with ozone use. Those who don’t use proper cleaning methods risk harmful exposures when the foam degrades. It warned that patients must stick to their device’s Instructions for Use for approved cleaning methods. The recall was announced by the FDA on June 30, 2021, in a Safety Communication. Several ventilator models were named.

According to the FDA’s recall notice, the polyester-based polyurethane (PE-PUR) sound abatement foam in Philips Respironics machines may break down and enter the air pathway of the device. The foam’s purpose is to reduce sound and vibration in the device. Unfortunately, exposure to carcinogens and debris from the disintegration of foam can have adverse health consequences such as hypersensitivity, nausea or vomiting, negative effects for other organs, inflammation, irritation, headache and asthma. More than 1200 complaints and over 100 injuries have been reported by users.

The company plans to correct the issue by replacing the existing sound abatement foam with a new foam. But many may have been injured by the release of carcinogenic material and debris already.

Chicago Attorneys for Nationwide Product Liability Lawsuits

When patients are injured by defective medical equipment, they may be able to sue for damages in a product liability lawsuit. In a lawsuit for defective machines, a manufacturer may be held accountable under a theory of strict liability, negligence or breach of warranty, depending on the state where the suit is brought. In a strict liability lawsuit in Illinois, you can hold the seller, manufacturer and others in the chain of distribution accountable if you were injured by a Philips Respironics machine. Our attorneys would need to show: (1) the machine was defective, (2) in its defective state it caused injuries.

There are three categories of actionable defects that may cause injury or death: design, manufacturing and marketing. With regard to Philips Respironics machines that have been recalled, it’s likely patients have design or marketing claims.

Design defects are flaws that are inherent to the product. In other words, you could bring a claim for design defects when flaws are in every specimen of the machine or ventilator in question. It may be appropriate to pursue design defect claims if the designer of the ventilators erred in using the foam component such that it is defective when manufactured as specified and used as intended and causes injuries.

In most cases, marketing defect cases involve failure to warn. For instance, if Philips Respironics knew about the risks of injuries and death arising out of the machine and failed to provide appropriate warnings and you were injured, you may have grounds to recover damages in a lawsuit arising out of marketing defects.

Manufacturing errors can also result in a ventilator becoming unsafe for use. For example, if the wrong materials were used for one specimen of the Philips Respironics machine you use to improve your breathing while sleeping, you might have a manufacturing defect claim.

Consult Seasoned Product Liability Attorneys

Whether you were injured or a loved one was killed because of the Philips Respironics CPAP machine, you should talk to the experienced Chicago-based lawyers of the Moll Law Group. For decades, we’ve represented many people who have been injured due to dangerous medical equipment. We compassionately represent consumers and provide a network of resources to the public for lifesaving and injury prevention information. We’re ready to help you assert your rights. Please contact us online or call us at 312.462.1700.

Philips Respironics CPAP Machine Recall Frequently Asked Questions:

Q: When will the devices start to be repaired or replaced?
A:
 Philips Respironics announced on September 1, 2021, “Philips anticipates rework to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices” and “intends to complete the repair and replacement programs within approximately 12 months.”

Q: Can Philips Respironics face any kind of fines or enforcement action by the FDA over its handling of this recall?
A:
If a firm’s voluntary action is not rapid or complete, the FDA has the option to take enforcement action. The FDA has identified this as a Class I recall, the most serious type of recall, and the FDA will continue to work with the company to ensure that they provide sufficient evidence demonstrating the safety and effectiveness of its proposed actions to correct the product defect. 

The FDA has also initiated on-site inspections of Philips Respironics’ manufacturing facilities to assess compliance with regulatory requirements.

Q: What medical devices are recalled?
A:
Philips Respironics announced recalls of their medical devices due to risk of exposure to debris and chemicals and potential health risks from PE-PUR sound abatement. The recalled devices are identified in Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication.

In addition to these recalls, Philips Respironics also recalled other ventilators, which the FDA identified as a Class 1 recall but is not related to the sound abatement PE-PUR foam issue: Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen.

Q:When a medical device is recalled, what is the FDA’s role?
A:
The mission of the FDA’s Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. When a medical device is recalled, the FDA evaluates the health hazard presented by the product issue and determines if the device is in violation of the Federal Food, Drug, and Cosmetic Act or otherwise fails to comply with FDA requirements. The FDA assigns the recall a classification (I, II, or III) to indicate the relative degree of risk (class I is the most serious). After the recall is classified, the FDA monitors the recall to ensure the recall strategy is effective and has been implemented.

When the FDA learns of a company’s decision to recall a device, the FDA reviews the adequacy of the firm’s proposed recall strategy and recommends changes as appropriate. After the recall is implemented by the firm, the FDA monitors the recall to ensure that the recall strategy is effective and has been implemented.

Q: I understand the sound abatement foam may be causing the problems related to the recall. Should I try and remove the foam from my device?
A: No. The FDA recommends you do not attempt to remove the sound abatement foam, as it may impact device performance and possibly introduce additional foam debris into the device air pathways. Philips Respironics is directly responsible for repair and replacement of all recall affected devices. 

Q: Can I be reimbursed for the cost of a replacement device?
A: Philips Respironics on September 1, 2021, “Philips anticipates rework to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices” and “intends to complete the repair and replacement programs within approximately 12 months.”

Q: If I obtain a new CPAP machine, what should I do with my recalled device?
A: Contact Philips Respironics or your health care provider for information on your local Philips Respironics representative to receive instructions and directions on how to return your recalled device(s). Do not discard or recycle the recalled device.

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