BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 13416220 · Received February 1, 2022

    Report

    Report Number
    2518422-2022-02740
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 6, 2022
    Report Date
    February 1, 2022
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    COMPONENTS THAT WERE REPLACED DURING SERVICE WERE RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION. DURING THE EVALUATION OF THE DEVICE'S SENSOR BOARD AT THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY, FLOW TESTS FAILED DUE TO FAULTY SENSORS MT2 AND MT5. THE COMPONENTS WERE SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974122 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown