A problem has been identified with the Philips Respironics Trilogy Evo 02, Trilogy Evo Universal, Trilogy EV300, and Trilogy Evo ventilators that could pose a risk for patients if not mitigated. Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.

All Trilogy Evo, Trilogy Evo 02, Trilogy EV300, and Trilogy Evo Universal models could be impacted by this issue.

Please note, these devices can continue to be safely used in line with the mitigations below as well as in accordance with the Instructions for Use.

To help 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 must be replaced between patients and monthly as indicated in the Instructions for Use. Using this filter was previously optional. This is now required.
• Use the air-inlet filter as indicated in the Instructions for Use.
• Installation of the particulate filter will not require a change to therapy settings.

To help detect change in therapy:

• Set appropriate alarms based on ventilation mode, such as Low Tidal Volume, Low Minute Ventilation, Low lnspiratory Pressure, and High lnspiratory Pressure.
• Check Proximal Pressure and External Flow Sensor Failed alarms can also alert the user to this issue. These are non-settable alarms.
• The device will issue a low priority Inlet Filter(s) Blocked alarm if therapy is reduced due to filter occlusion. The device will continue to function if this occurs, but the user must be aware to rinse the air-inlet filter and replace the particulate filter if this occurs.
• Observe instructions for any alarm, especially Ventilator Service Required or Ventilator Inoperative. If the situation cannot be resolved, use alternative ventilation equipment.

Actions planned by Philips Respironics to correct the problem:

• Use of a particulate filter is now required for all devices.
• Philips Respironics is updating the Trilogy Evo configurations to include the particulate filter in the device packaging from the factory. Additionally, Philips Respironics will distribute one particulate filter to all Trilogy Evo owners who have previously purchased a device.
• Trilogy Evo 02, Trilogy EV300, and Trilogy Evo Universal configurations will continue to include the particulate filter with the device from the factory.
• Philips Respironics will replace the machine flow sensor of impacted devices meeting the following criteria:
  • The device was purchased prior to the distribution of this notice.
  • The device has issued a Ventilator Service Required or Ventilator Inoperative alarm due to accumulation of environmental debris on the machine flow sensor which has been confirmed by the Philips Respironics service network.
  • Philips Respironics is informed of the malfunction within 2023 calendar year.
• Additional filters are available through the standard Philips Respironics ordering process.
• Philips Respironics is investigating the issue further to determine if additional action is required

Please take the actions above in order to prevent risk for your patients.

If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Respironics Customer Service at 1 (800) 345-6443 for homecare customers or 1 (800) 722-9377 for hospital customers.