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Today, the U.S. Food and Drug Administration (FDA) is providing an update on the Philips Respironics (Philips) June 2021 recall. Philips has informed the FDA that the Philips Trilogy ventilators reworked as a part of the June 2021 recall have two new potential issues. The FDA 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.
- Issue 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.
- Issue 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.
We will keep the public informed as more information becomes available.
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Questions?
For questions about repaired Trilogy ventilators, see Philips Trilogy 100/200 ship hold - Customer update or contact Philips Sleep and Respiratory Care support at 1-877-907-7508 or visit Philips Information for Patients.
The FDA.gov website includes FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls to address questions about the recalls and provide additional resources with more information on the June 2021 recall.
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