This is an important update about the June 2021 Philips ventilators recall using some remarkable findings set forth in an FDA Form 483 issued to Philips Respironics on November 9, 2021.
First, from a November 16, 2021 article, “FDA inspection turns up more problems for Philips Respironics”, published on the Regulatory Affairs Professionals Society (RAPS) site, about FDA Form 483 issued in connection with the Philips ventilators recall:
The investigation also found that Philips had ignored earlier red-flag signs that foam was breaking down and entering the breathing tube of their products, with executive-level managers having been aware of “potential foam degradation issues concerning CPAPs, BiPAPs and Trilogy ventilators since at least 1/31/2020,” wrote FDA investigator Katelyn Staub-Zamperini.
Second, a November 15, 2021 article, “FDA Inspection of a Philips Facility Raises Red Flags”, published on the Medical Device and Diagnostic Industry (MD+DI) site, covers the critical point that the FDA’s findings suggest that Philips Respironics had known for several years about the potential foam degradation issues that gave rise to the June 2021 Philips ventilators recall. We get this excerpt from the “Philips knew about the foam degradation problem 6 years ago” part of that MD+DI article:
The investigator’s report also points out that around Nov. 25, 2015, Philips was aware of a preventative maintenance servicing procedure implemented by another Philips entity on Trilogy ventilator products regarding foam degradation issues and complaints in the field. However, Philips Respironics either did not perform or did not document any further investigation, health hazard evaluation, risk analysis, or design review of the issue. The company did, however, provide the investigator with an email that the other Philips entity sent on Nov. 25, 2015, detailing the preventative maintenance procedure and timeline.
Third, from a November 15, 2021 article, “Damning FDA-483: Philips Didn’t Investigate 222,000 Complaints Of Possible Degraded Foam In Breathing Devices”, written by Shawn M. Schmitt for Medtech Insight:
In one of the more damning observations made by investigator Katelyn Staub-Zamperini during the 26 August-9 November inspection, Philips apparently opened no formal investigations after it received hundreds of thousands of complaints of particles and other contaminants when the devices were used.
Our law firm is investigating Philips ventilators recall lawsuits for patients who have been diagnosed with cancer, lung disease, and kidney or liver failure, as well as other medical conditions.
If you or someone you know used one of the recalled Philips Bi-Level PAP, Philips CPAP, or Philips Mechanical Ventilator devices and, in turn, developed cancer or experienced organ failure, we are providing free case evaluations for possible lawsuits against Philips.[Read article in full at original source]
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