Philips Revises User Guidelines for Trilogy Evo Series and Other Ventilators amid Concerns of Flow Measurement Errors Linked to Specific In-Line Nebulizer Configurations

Philips Revises User Guidelines for Trilogy Evo Series and Other Ventilators amid Concerns of Flow Measurement Errors Linked to Specific In-Line Nebulizer Configurations

This recall pertains to revising usage instructions for devices, which does not involve their removal from clinical or retail environments. The FDA categorizes this recall as the most severe type. Continued use of this device without adhering to the revised instructions may result in severe injury or death.

Products Affected

  • Device Names: Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2 
  • Model Numbers: DS2110X11B, DS2100X11B, DS2200X11B, DS2000X11B, VT2110X24B, LD2110X23B, and SP2100X26B
  • Lot/Serial Numbers: All  

Recommended Actions

  • Be aware that the issue may impact any device previously used in conjunction with in-line nebulizer treatments. 
  • Adhere to the following usage instructions:
    • Ensure all alarm settings are appropriately configured.
    • Maintain supplementary ventilation options in case the ventilator fails or operates incorrectly. 
  • Refer to the provided image for acceptable nebulizer circuit configurations below. 
acceptable in-line nebulizer placement circuit

On October 7, 2024, Philips distributed an Urgent Medical Device Correction letter to all affected clients advising on the following precautions.

For users of Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2:

  • Recognize that any of these devices previously utilized with an in-line nebulizer in particular configurations could be affected.
    • Aerosol builds up over time and might jeopardize the functionality of the internal flow sensor. 
  • Verify that critical alarms are set for each patient.
  • Have alternative ventilation sources at hand should the ventilator become nonfunctional. 

If utilizing a specified FiO2 oxygen concentration setting:

  • Implement continuous pulse oximetry (SpO2) monitoring as per treatment guidelines. 
  • Ensure that patients are receiving sufficient oxygen by employing an external FiO2 analyzer for relevant cases, and switch to another ventilator if no analyzer is available. 
  • Keep a readily accessible back-up device or alternative ventilator for immediate therapy transition (as indicated in the Instructions for Use).

For in-line nebulizer treatments:

  • Adhere to the instruction notice above for appropriate nebulizer placement. 
  • Adjust patients to alternative device settings based on specific prescriptions in the notification.

Justification for Instruction Updates  

Philips is revising instructions for the Trilogy Evo line due to the chance of aerosol residue forming on the internal flow sensor when in-line nebulizers are positioned incorrectly. This interference can lead to misleading flow readings, resulting in patients potentially receiving excess tidal flow or inadequate oxygen without the operator being aware. 
 
The usage of the affected devices may lead to serious health repercussions, including respiratory issues, lung injury (volutrauma/barotrauma) from excessive tidal volume, low oxygen saturation, shortness of breath (dyspnea) from delayed therapy or insufficient oxygen, and even death.  

There have been four documented injuries associated with this issue. 

Device Applications 

Philips Respironics Trilogy Evo and similar ventilators deliver continuous positive airway pressure (CPAP) and intermittent positive airway pressure for individuals needing mechanical ventilation. They are intended for patients ranging from pediatric to adult, weighing at least 2.5 kg, and can be utilized in hospitals, healthcare environments, or for nonemergency patient transportation. The Trilogy EV300 and Trilogy Evo are additionally suitable for home mechanical ventilation.

Contact Details 

U.S. durable medical equipment (DME) and home care clients with inquiries should reach out to Philips at 1-800-345-6443, opting for 4, then 5. Hospital customers can call: 1 (800) 722-9377, option 2.

Extra FDA Resources

Additional Company Information

Unique Device Identifier (UDI) 

The unique device identifier (UDI) enhances the tracking of individual medical devices sold in the U.S. encompassing their production and distribution to patient usage. This improvement facilitates better reporting, reviewing, and assessing adverse events so issues can be diagnosed and rectified expeditiously. 

How to Report Issues? 

Healthcare professionals and consumers may report adverse reactions or quality concerns experienced with these devices through the MedWatch program, which is dedicated to safety information and adverse event reporting.