Trilogy Evo Universal Ventilator, Model Number DS2000X11B

FDA device recall Z-1652-2023 · posted 2023-06-02 · Open, Classified

Recall details

Recalling firm

Philips Respironics, Inc.

Reason for recall

The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.

Action taken

An URGENT Medical Device Correction notification letter was sent to customers on 5/1/23. Please take the actions below in order to prevent risk for your patients. Actions that must be taken by the user in order to prevent risks for patients. 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 Inspiratory Pressure, and High Inspiratory 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. Ensure ventilator dependent patients have access to alternative ventilation equipment, such as a back up ventilator or manual resuscitator. Distribute this notice to all employees in your organization that need to be aware. Train device users within your network to use the air inlet and particulate filters on all patients. Send this notice to any organization an impacted device was sold or distributed to. If you need any further informatio

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CBK

Quantity affected

22,237 devices

Distribution

US Nationwide. Global Distribution.

Date initiated

2023-05-01

Date posted

2023-06-02

Location

Murrysville, PA

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