Philips Reports Potential Issues with Recalled Trilogy Ventilators
Philips Respironics has informed the FDA of two new potential issues with its reworked Trilogy ventilators that were part of a June 2021 recall.
The first issue is the new silicon sound abatement foam installed in the reworked ventilators to replace the old polyester-based polyurethane (PE-PUR) foam. The new foam can separate from the plastic backing and block the air inlet, lowering the inspiratory pressure and setting off a low pressure alarm.
The second issue is that some particulate matter has been found in the air pathway of some of the reworked ventilators. Lab results showed PE-PUR and/or environmental debris in the samples sent to a third-party lab for evaluation.
The FDA said it is not changing its current recommendations for the recall, which is to seek a replacement device from the manufacturer.