New information out of the Food and Drug Administration related to the ongoing recall of various models of Philips respiratory aids was very bad news for the company. In two updates released just days apart, the federal agency indicated that not only had the number of reports received over breakdowns in the foam used to insulate the mechanics of the devices crested 20,000 in just one quarter, but that redesigns and changes to the devices made in response to the recalls may have led to problems of their own.
In a November 17 post to its website, the FDA notes that “Philips has informed the FDA that the Philips Respironics Trilogy ventilators reworked as a part of the June 2021 recall have two new potential issues.” The FDA is investigating the issue further and has asked the company for additional details, however initial reports show significant flaws.
The first issue stems from the fact that the new foam being used in place of the polyester-based polyurethane foam can break free from the backing of the device and block its air inlet. Such a blockage can trigger an alarm in the device, such as a Low Inspiratory Pressure alarm.
The second issue is that the same particulate matter that was being off-gassed by the polyester-based polyurethane foam in recalled devices is still showing up in the air pathways of re-configured devices. The new design calls for a silicone-based foam to be used which should not emit such materials. However, recalled units that have been repaired and changed over to the silicone-based foam material are still showing evidence of the presence of polyester-based polyurethane foam particles.
Days later, an FDA report was issued indicating that 21,000 medical device reports had been filed in the three-month period spanning August 1, 2022, and October 31, 2022. Philips blamed the high number of reports on the publicity the issue has received while making no mention of the fact that the foam used in the devices was carcinogenic to humans and actively entering the airway of its devices, leading to the deaths of over 100 patients.
