BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EV300, USA

    MDR report key: 24020908 · Received January 9, 2026

    Report

    Report Number
    2518422-2026-001344
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 17, 2025
    Report Date
    January 9, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959052017
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EV300 VENTILATOR FAILED ACTIVE EXHALATION CONTROL MODULE (AECM) VERIFICATION TESTING. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY WAS REPORTED. REPAIR OF THE DEVICE FOR THE REPORTED TEST FAILURE INDICATES REPLACEMENT OF THE PROPORTIONAL VALVE (AECM) AND THE 3-WAY SOLENOID VALVE IS NEEDED TO ADDRESS THE ISSUE. 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
    87545 TRILOGY EV300, USA VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2200X11B 00606959052017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown