FDA Reviewing Medical Device Reports for Philips CPAP Recall

FDA medical device reports

Since April 2021, the FDA has received more than 69,000 medical device reports (MDRs), including 168 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown, which led to the Philips CPAP recall.

Source: FDA Safety Communication


FDA Safety Communication Update

Philips CPAP recall, FDA The US FDA has received more reports of adverse outcomes, including deaths, from the breakdown of foam in many sleep apnea devices from Philips.

August 16, 2022, the FDA released an update on the Philips CPAP, BiPAP and ventilator recall. The safety communication added the latest information about MDRs received May 1, 2022 to July 31, 2022 associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam used in the machines included in the June 2021 recall.

Click here for full list of recalled devices.


Medical Device Reports (MDRs)

Manufacturers are required to submit MDRs when information reasonably suggests that their device may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device they manufacture would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

FDA, medical device reports, MDRsSince April 2021, the FDA has received more than 69,000 MDRs, including 168 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown.

  • From April 2021 through April 30, 2022, the FDA received more than 21,000 MDRs, including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown.
  • From May 1, 2022, through July 31, 2022, the FDA received more than 48,000 medical device reports, including 44 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown.

A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea, dizziness, nodules, and chest pain. The FDA will examine the possible reasons for the increased number of reports during this time.


Philips CPAP Lawsuits

The litigation has been centralized before U.S. District Judge Joy Flowers Conti in the Western District of Pennsylvania for coordinated discovery and pretrial proceedings.

Thousands of users of the recalled devices have filed and continue to file notice of their intention to pursue a lawsuit. Plaintiffs allege the foam caused cancer to develop or chronic exposure resulted in lung injuries, such as pulmonary fibrosis, interstitial lung disease, sarcoidosis and others.

Do you have a Philips CPAP Recall case?


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If you or a loved one developed cancer, respiratory issues, or other serious health problems after using one of the defective Philips CPAP machines, contact the law offices of Nash & Franciskato at (877) 284-6600. The time to request your free, no-obligation case review is today. We will help you determine if your Philips breathing device is the cause of your health issues.

Call us today at (877) 284-6600. One of our experienced staff will speak with you personally and will provide you with a free, no-obligation review of your case.

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