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  5. Ventilator Correction: Philips Updates Use Instructions for Trilogy Evo, EvoO2, EV300, Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2 due to Risk of Inaccurate Flow Measurements Caused By Certain In-Line Nebulizer Placements
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Ventilator Correction: Philips Updates Use Instructions for Trilogy Evo, EvoO2, EV300, Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2 due to Risk of Inaccurate Flow Measurements Caused By Certain In-Line Nebulizer Placements

This recall involves updating instructions for using 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 following the updated instructions.

Affected Products

  • Product 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   

What to Do  

  • Be aware that this issue may affect any device that has ever been used with in-line nebulizer treatments. 
  • Follow the instructions for use:
    • Make sure all alarms are set appropriately.
    • Keep alternate ventilations sources available in case the ventilator stops working or doesn’t work properly. 
  • See acceptable in-line nebulizer placement circuit image below. 
acceptable in-line nebulizer placement circuit

On October 7, 2024, Philips sent all affected customers an Urgent Medical Device Correction letter recommending the following actions.

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

  • Be aware that this issue may affect any Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2 devices that have historically been used with an in-line nebulizer in certain configurations.
    • Nebulized aerosols accumulate over time and can permanently impact the internal flow sensor.  
  • Make sure that specific alarms are set appropriately for patients.
  • Ensure that alternate sources of ventilation are available in case a ventilator ceases to function. 

If using with a set FiO2 oxygen concentration setting:

  • Use continuous pulse oximetry (SpO2) monitoring according to treatment protocols. 
  • Make sure patients receive adequate oxygen by using an external FiO2 analyzer in specific patient cases, and switch to an alternative ventilator if an external FiO2 analyzer is not available. 
  • Maintain an immediately available back‐up device or alternative ventilator for rapid therapy transition (indicated in Instructions for Use).

If using in-line nebulizer treatments:

  • Follow the visual instructions notice (above) for correct nebulizer placement. 
  • Transition patients to alternate device configurations for specific prescriptions as outlined in the letter.

Reason for Updates to Use Instructions   

Philips is updating use instructions for Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2, due to the risk of aerosol deposits accumulating over time on the device’s internal flow sensor when in-line nebulizers are used in certain locations. Impacted flow sensors may cause inaccurate flow measurements, leading to patients inadvertently experiencing too much air (tidal) flow or not enough oxygen without awareness of the ventilator operator. 
 
The use of affected product may cause serious adverse health consequences, including respiratory discomfort, lung damage (volutrauma/barotrauma) from over-delivery of tidal volume, low oxygen saturation and/or shortness of breath (dyspnea) from therapy delays or under-delivery of oxygen and death.  

There have been four reported injuries. 

Device Use 

Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2 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  

Durable medical equipment (DME) and home care customers in the U.S. with questions should contact Philips at 1-800-345-6443, option 4, then option 5. Hospital customers should call: 1 (800) 722-9377, option 2. 

Additional FDA Resources

Additional Company Resources

Unique Device Identifier (UDI) 

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly. 

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. 

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