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.
Affected Product
The FDA is aware that Philips has issued a letter to affected customers recommending all Trilogy ventilators be corrected prior to continued use. Affected devices:
| Device Name | Model Number | UDI-DI |
|---|---|---|
| Trilogy Evo | DS2110X11B | 00606959051942 |
| Trilogy EV300 | DS2200X11B | 00606959052017 |
| Trilogy Evo O2 | DS2100X11B | 00606959051997 |
| Trilogy Evo Universal | DS2000X11B | 00606959052000 |
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.
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.
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.
Device Use
Philips Respironics Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators provide continuous positive airway pressure (CPAP) and intermittent positive airway pressure breathing support for people who need mechanical ventilation. They are intended for pediatric through adult patients weighing at least 2.5 kg and are used in hospitals and health care settings and for patient nonemergency transport. The Trilogy EV300 and Trilogy Evo may also be used by people requiring mechanical ventilation in their homes.
Contact Information
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.
Additional FDA Resources
- FDA Enforcement Report - Event 98537
- CDRH Medical Device Recall Database - Event 98537
- FDA Enforcement Report - Event 98540
- CDRH Medical Device Recall Database - Event 98540
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.