BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY100

    MDR report key: 18242735 · Received November 30, 2023

    Report

    Report Number
    2518422-2023-32790
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    November 22, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959015364
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN ERROR CODE 110, 165 AND 291 WERE OBSERVED. THE CUSTOMER HAS REQUESTED NO REPAIRS TO THE DEVICE TO BE DONE. THE INLET AIRPATH ASSEMBLY AND REMOVABLE AIR PATH FOAM WERE REPLACED PER REMEDIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398964 TRILOGY100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260 00606959015364

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown