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Philips Reports Potential Issues with Recalled Trilogy Ventilators

November 23, 2022

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.

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