BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO

    MDR report key: 22464270 · Received July 9, 2025

    Report

    Report Number
    2518422-2025-107219
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 9, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959055483
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION HAD OCCURRED ON THE TRILOGY EVO DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE MANUFACTURER¿S SERVICE TECHNICIAN CONFIRMED THE CUSTOMER¿S ISSUE AND OBSERVED ERROR CODES MOTOR SHUTDOWN, MOTOR FLUX MAGNITUDE RUNTIME, AND MOTOR CONTROLLER FOC SHUTDOWN IN THE DEVICE¿S EVENT LOG. THE MANUFACTURER¿S SERVICE TECHNICIAN REPLACED THE DEVICE'S BLOWER ASSEMBLY AND SYSTEM PRINTED CIRCUIT ASSEMBLY BOARD TO ADDRESS THE MOTOR SHUTDOWN, MOTOR FLUX MAGNITUDE RUNTIME, AND MOTOR CONTROLLER FOC SHUTDOWN ISSUES. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE THE MANUFACTURER¿S SERVICE TECHNICIAN REPLACED THE AIR INLET FOAM FILTER PROACTIVELY TO PROTECT THE DEVICE AND THE PATIENT'S RESPIRATORY TRACT FROM DUST. AFTER THE PARTS WERE REPLACED, THE MANUFACTURER¿S SERVICE TECHNICIAN PERFORMED THE FINAL TEST ON THE DEVICE. THE DEVICE PASSED THE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169320 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. KR2110X15B 00606959055483

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown