Voluntary Field Safety Notice related to Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal
Initiated March 2023
Philips Respironics has discovered, through internal testing, that accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may vary based on the patient’s lung capacity, lung resistance, use of a particulate filter, or circuit configuration. In the worst case, this may lead to under delivery of oxygen.
The potential for this hazard is most likely to occur when the oxygen blending module (OBM) is used to manage patients requiring high volumes of oxygen such as scenarios requiring FiO2 setpoint greater than or equal to 70%.
Please note, these devices can continue to be safely used in line with the mitigations described within the Field Safety Notice.