FDA Calls on Philips Respironics to Offer New Repair or Replacement Plan for Defective Ventilators
A branch of the U.S. Food & Drug Administration (FDA) is proposing that Philips Respironics submit a new plan for handling defective CPAP, BiPAP, and mechanical ventilator machines. The Center for Devices and Radiological Health (CDRH) is suggesting the company offer an updated road map for the repair, replacement, or refund for the devices affected by the manufacturer’s recent market recall.
Before the FDA issues a final order on the issue, Philips can receive a hearing. The FDA previously ordered the company to notify customers about the recall.
Device Recall Affects Millions of Patients
Philips Respironics recalled several types of CPAP, BiPAP, and mechanical ventilator devices in 2021, which the company estimated could affect between 3 million to 4 million people. People who use these devices have sleep apnea and need breathing support at night and in other clinical settings. (Philips)
The recall stems from defects related to a sound-abatement foam that could degrade inside the devices over time. Made of polyester-based polyurethane (PE-PUR), a possible carcinogen, patients could be exposed to toxic foam particles in the device’s airway. Additionally, this PE-PUR foam is known to have toxic off-gassing qualities, exposing users to volatile organic compounds (VOCs).
As a result, people who used the defective devices could have experienced a range of symptoms and health complications, such as asthma, inflammatory responses, or even cancer. (FDA) A mass tort is now pending against Philips for damages related to these defective products, and thousands of plaintiffs are expected to join the suit.
Why Is the FDA Proposing that Philips Submit a New Repair or Replacement Plan?
After its June 2021 product recall, Philips proposed an initial plan to repair the affected devices. The plan would exchange existing PE-PUR foam in the machines for new silicone-based foam. The FDA approved the proposal based on the safety documentation available to the agency at the time.
However, after the FDA investigated a Philips manufacturing facility later that year, it found that the proposed silicone foam had failed some safety testing. The FDA has since requested that Philips supply testing data from an independent lab and subsequently revise its plan to repair, replace, or refund devices.
What Patients Should Know About Recalled Devices
The FDA states that patients with Philips CPAP, BiPAP, or mechanical ventilators should first speak with their doctors about their options for treatment before discontinuing use of an affected device.
To determine if you have a recalled device and learn what comes next after registering a defective machine, an informational video is available from Phillips. (Philips Healthcare) Once you register your device, Philips should follow up with information regarding your replacement options. New information about an updated repair or replacement program may be forthcoming from the manufacturer, however.
Learn More About Your Legal Options if You Were Harmed After Using a Defective Device
If a recalled Philips CPAP, BiPAP, or mechanical ventilator device injured you, you could seek compensation for your damages. Fill out our online contact form to get a case review from a Philips CPAP Mass Tort lawyer in our network.