Philips is recalling Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators after detecting dust and dirt from the environment in the air path of some devices, according to an FDA advisory dated Aug 14, 2023. According to the alert, extended exposure to environmental contaminants such as dust and dirt can lead to buildup that may block air vents and cause the device to stop delivering the right amount of air pressure, or air volume/flow.
If the ventilator fails to provide the right level of breathing support, patients may not receive enough oxygen (hypoventilation) and may experience a build-up of carbon dioxide or other gas pressure, which can lead to serious injury or death.
According to the FDA, one death and two injuries have been reported related to this issue, and a total of 542 reports.
The FDA posted the following instructions from Philips for users to prevent incidents:
Actions for users to prevent risk to patients. (Source: FDA)
- Prevent accumulation of debris on the machine flow sensor:
- Use the Philips approved particulate filter, which prevents a significant majority of airborne aerosols and particulate from entering the device. This filter is now required.
- Replace the filter between patients as indicated in the Instructions for Use.
- Use the air-inlet filter as indicated in the Instructions for Use.
- Note: Installation of the particulate filter does not require a change to therapy settings.
- Detect changes in therapy.
- Set appropriate alarms based on ventilation mode, such as Low Tidal Volume, Low Minute Ventilation, Low Inspiratory Pressure, and High Inspiratory Pressure.
- The Check Proximal Pressure and External Flow Sensor Failed alarms can also alert the user to this issue—these are non-settable alarms.
- Inlet Filter Blocked alarm will sound if therapy is reduced due to filter blockage. User must rinse the air-inlet filter and replace the particulate filter if this occurs.
- Follow instructions for any alarm, especially Ventilator Service Required or Ventilator Inoperative.
- Use alternative ventilation equipment if the situation cannot be resolved.
- Make sure ventilator-dependent patients have access to alternative ventilation equipment, such as a back-up ventilator or manual resuscitator.
- Set appropriate alarms based on ventilation mode, such as Low Tidal Volume, Low Minute Ventilation, Low Inspiratory Pressure, and High Inspiratory Pressure.
