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Ventilator Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators
The FDA is aware that Philips has issued a letter to affected customers recommending all Trilogy ventilators be corrected prior to continued use. This includes Trilogy EVO, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal devices.
Philips has identified three issues affecting Trilogy Evo Platform ventilators:
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Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
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Aerosol buildup on the internal flow sensor may interfere with the sensor’s ability to accurately measure airflow, leading to incorrect flow calculations and potentially impacting the therapy delivered to the patient.
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In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards – two breath cycles or five seconds. In certain ventilation modes, with or without backup rates, the alarm could be delayed by up to four breaths.
This recall involves correcting devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
DME and Homecare Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Philips at 1-800-345-6443, press option 2 for repair and then option 1. Hospital customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Philips at 1 (800) 722-9377, press option 2.
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