Philips Trilogy ventilators reworked as a part of the June 2021 recall have two new potential issues that may affect performance and safety, according to an FDA alert on Thursday.

According to the FDA, the two issues are:

  1. The new silicone sound abatement foam, installed in the reworked ventilators to replace the polyester-based polyurethane (PE-PUR) foam, may potentially separate from the plastic backing and could impact the performance of the device by potentially blocking the air inlet and thus lowering the inspiratory pressure. If the air pressure is significantly impacted, the device could issue a ventilator alarm, such as the Low Inspiratory Pressure alarm.
  2. Trace amounts of particulate matter have been found in the air pathway of some reworked ventilators. Particulate samples were sent to a third-party lab for evaluation. Preliminary results show PE-PUR and environmental debris in some samples, and in others only environmental debris.

According to the FDA, the agency has requested additional information from Philips to better understand the cause of the issues and to provide informed recommendations to patients, caregivers, and health care professionals.

 More information will be available on the FDA website.