Philips has issued updated use instructions for several ventilator models following an FDA Class I recall due to risks of aerosol deposits accumulating on internal flow sensors when in-line nebulizers are used.

RT’s Three Key Takeaways:

  1. Updated Use Instructions Issued: Philips has provided revised guidance to address the risk of aerosol deposits on ventilator flow sensors, which may lead to inaccurate airflow or oxygen delivery.
  2. Serious Health Risks Identified: The FDA classified this as a Class I recall, warning of potential injuries such as lung damage, low oxygen saturation, or even death if the guidelines are not followed.
  3. Backup Devices Recommended: Users are advised to have alternate ventilators available, monitor oxygen levels closely, and ensure alarms are properly configured to prevent therapy delays and improve patient safety.

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 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 from over-delivery of tidal volume, low oxygen saturation and/or shortness of breath from therapy delays or under-delivery of oxygen and death. There have been four reported injuries. 

This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The US Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type. The FDA notes these devices may cause serious injury or death if you continue to use them 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   

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. 

[RELATED: Philips Issues Trilogy Ventilator Software Update to Resolve Safety Risks]

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.  

What to Do  

On Oct 7, Philips sent 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.

Photo caption: Trilogy Evo

File photo/Philips