Philips Respironics has identified two potential issues that could impact patient safety if not mitigated. Please note, these devices can continue to be safely used in line with the mitigations described below and within the Field Safety Notices. Providing patients with safe and high-quality therapy devices is our top priority. We encourage you to read the field safety notices on this page to learn more about the mitigating actions you can take to ensure safe continued use.
(2022-CC-SRC-049) Initiated March 2023 This issue affects the Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal only. 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%. This issue does not affect the Trilogy Evo device which is typically used in the home environment. The Medical Device Correction provides immediate solutions to address safe continued use of the ventilators.
Providing patients with safe and high-quality therapy devices is our primary focus. We encourage you to read the Trilogy Evo FiO2 Medical Device Correction to learn more about the mitigating actions you can take to ensure safe continued use.
(2023-CC-SRC-003) Initiated April 2023 This issue affects all Trilogy Evo Platform devices (Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, Trilogy EV300)
Philips Respironics has detected contamination in the air path of some devices that have been returned from the field. Philips Respironics has confirmed the material is environmental contamination, such as dust and dirt. Extended exposure to these environmental contaminants can lead to buildup of particulate on a flow sensor within the device. This may cause the device to inaccurately deliver pressure, volume, or flow.
Please note, when the mitigating actions specified in the Trilogy Evo platform of ventilators Field Safety Notice are taken, the Trilogy Evo platform of ventilators continues to be an alternative for:
As a health technology company, it is critical that we have and abide by strong quality and regulatory processes. The release of the field safety notice further enforces Philips Respironics dedication to patient safety by informing customers about issues that could potentially affect patients, and providing solutions that address these concerns.
If you have any questions or need further support concerning this issue, please contact your local Philips representative.
We appreciate your patience and trust as we continue to act quickly to release this correction.
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