FDA reports issues with certain reworked Philips ventilators

Philips has reported two potential issues with Respironics Trilogy ventilators that were recalled in June 2021 and reworked, the Food and Drug Administration announced last week. The silicone sound abatement foam used to replace the polyester-based polyurethane foam may separate from the plastic backing, potentially blocking the air inlet and lowering inspiratory pressure, FDA said. Philips also found trace amounts of particulate matter in the air pathway of some reworked ventilators. The FDA has requested additional information from Philips to better understand the cause of the issues and inform recommendations, and said it will inform the public as more information becomes available.