Summary: Philips has updated instructions for Trilogy Evo ventilators to address aerosol deposits on internal sensors when used with in-line nebulizers, potentially causing inaccurate flow measurements and serious health risks.

Key Takeaways:

  • Aerosol deposits from in-line nebulizers can accumulate on the ventilator’s internal flow sensor, leading to inaccurate flow measurements.
  • Philips provided updated instructions that outline proper nebulizer placement and configuration adjustments.

Philips issued updated 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.

Serious Risks Highlighted

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.

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Actions for Users

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.

Ventilator Overview

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 healthcare settings and for patient non-emergency transport. The Trilogy EV300 and Trilogy Evo may also be used by people requiring mechanical ventilation in their homes.