WASHINGTON—Philips issued a letter recommending that all of its Trilogy ventilators be corrected before continued use. The U.S. Food & Drug Administration (FDA) identified this recall as the most serious type, as the devices may cause serious injury or death if they continue to be used without correction. The recall involves correcting devices; however does not require removing them from where they are used or sold.
Affected Products
The affected products include:
| Device Name | Model No. | UDI DI |
| Trilogy Evo | DS2110X11B | 00606959051942 |
| Trilogy EV300 | DS2200X11B | 00606959052017 |
| Trilogy Evo O2 | DS2100X11B | 00606959051997 |
| Trilogy Evo Universal | DS2000X11B | 00606959052000 |
A full list can be found here.
What to do
The FDA recommended that all Trilogy Evo Platform ventilators are updated with software version 1.05.15.00 and that all use of non-pneumatic nebulizers be discontinued with all Trilogy Evo Platform ventilators. Users should also review the latest User Manual Addendum.
The letter Philips sent to all affected customers recommended 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.
Reason for Recall
Philips has identified three issues affecting Trilogy Evo Platform ventilators:
Use of Non-pneumatic (e.g., Vibrating Mesh) Nebulizers Prohibited
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. Non-pneumatic nebulizers change the airflow characteristics by adding liquid droplets, causing the ventilator’s leak estimation calculation to be incorrect. This leads to under-delivery of therapy to the patient, even though the graphic user interface does not display the change. This condition may occur with or without aerosol accumulation on the flow sensor. Potential harms include hypoventilation, low oxygen saturation, inadequate or inappropriate treatment, dyspnea and other respiratory problems.
Incorrect flow calculations
Depending on where a nebulizer is placed on the patient circuit, aerosol can enter the ventilator and accumulate on the internal flow sensor. Over time, this buildup 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 these cases, the internal flow sensors should be replaced.
Aerosol deposits that accumulate on the flow sensor may cause over-delivery of tidal volume, under-delivery of FiO2, and in some cases, a Ventilatory Inoperative condition. Potential harms in this situation may include over inflation of the lung, low oxygen saturation, hypoventilation, delay/absence of therapy and respiratory discomfort.
Obstruction alarm timing
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.
As of March 6, Philips has reported three serious injuries and no deaths associated with these issues.
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.