FDA Alert: Philips Issues Correction for Trilogy Evo Platform Ventilators

The Office of Developmental Programs (ODP) shared this important announcement from the U. S. Food and Drug Administration (FDA). 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:

• 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.
• 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.
• 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. View the full list of affected products here.

What to Do:

Update all Trilogy Evo Platform ventilators with software version 1.05.15.00. Stop all use of non-pneumatic nebulizers with all Trilogy Evo Platform ventilators. Review the latest User Manual Addendum.

On March 2, Philips sent all affected customers a letter recommending the following actions:

• Update all Trilogy Evo Platform ventilators with software version 1.05.15.00. The software is available as free download through the My Philips for Professionals (MyP4P) and InCenter websites.
• Review the latest version of the User Manual Addendum. Ensure a copy of all product literature, including the User Manual Addendum, is included with every Trilogy Evo Platform ventilator in your fleet.
• Stop all use of non-pneumatic nebulizers, including vibrating mesh nebulizers, with all Trilogy Evo Platform ventilators.
• Communicate this notice to anyone in your organization who interacts with a Trilogy Evo Platform ventilator, including clinicians, therapists, nurses, caregivers, and patients. Ensure they are aware of the changes regarding the use of nebulizers with these ventilators and that non-pneumatic nebulizers are not to be used.
• If a Trilogy Evo Platform ventilator previously in your possession has been transferred, ensure this information is communicated to them, including the User Manual Addendum.

Visit the FDA’s website for additional information and next steps.