BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EV300, USA

    MDR report key: 23082661 · Received September 18, 2025

    Report

    Report Number
    2518422-2025-110334
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    September 8, 2025
    Report Date
    September 18, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959052017
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EV300 VENTILATOR FAILED PRELIMINARY SYSTEM TESTING OF THE ACTIVE EXHALATION CONTROL MODULE (AECM). THE DEVICE WAS NOT REPORTED TO BE IN USE WITH A PATIENT AND NO HARM, OR INJURY WAS REPORTED. THE TRILOGY EVO 3-WAY SOLENOID VALVE AND PROPORTIONAL VALVE REQUIRE REPLACEMENT TO ADDRESS THE AECM TEST FAILURE. THE DEVICE REMAINS AT THE CUSTOMER SITE AND ON-SITE REPAIR OF THE VENTILATOR WAS PLANNED FOR COMPLETION 17 SEPT 2025. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2598958 TRILOGY EV300, USA VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2200X11B 00606959052017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown