In June 2021, the medical device manufacturer Philips issued a voluntary recall of several sleep apnea machines and ventilators containing defective PE-PUR sound abatement foam. The foam in question could degrade over time, emitting toxic and cancer causing debris and fumes to the user.
Later that month, the FDA issued a safety communication on Philips Respironics recalled ventilators, BiPAP, and CPAP machines containing the defective PE-PUR foam which provided additional information on the recalled items. Since the initial recall, the FDA has issued updates concerning the recalled products and Philips has taken additional actions.
The FDA had previously approved Philip’s repair and replace program, which replaced defective CPAP, Bi-PAP and mechanical ventilators utilizing the PE-PUR foam with a silicone-based foam. The FDA later found that the silicone based foam had failed a singular safety test for the release of volatile organic compounds in a non-U.S. market. The FDA requested that Philips get independent testing, which would determine any safety risks to users with the machines using the silicone-based foam.
In a recent FDA inspection, it was determined that a Philips supplier had incorrectly used the problem PE-PUR foam to manufacture certain Trilogy Evo ventilators with specific serial numbers. These ventilators had not been included in the June 2021 recall.
In December 2021, Philips initiated a recall of the Trilogy Evo ventilators distributed between April 15, 2021 and May 24, 2021. On January 26, 2022, the FDA provided an update related to these Trilogy ventilators, listing them as a Class 1 recall, the most severe type of recall.
The FDA says that prolonged exposure to the hazardous PE-PUR foam can cause serious health problems including headaches, asthma, adverse effects on the kidneys or liver, irritation of the eyes, skin or respiratory system, and cancer.
If you have suffered from health complications after using any of the recalled Philips CPAP, Bi-PAP or ventilators, including the Trilogy Evo ventilator, you may be entitled to compensation. Contact the team of experienced attorneys at Cellino Law today for your free case evaluation.