BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 12092379 · Received June 30, 2021

    Report

    Report Number
    2518422-2021-01998
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 24, 2021
    Report Date
    June 30, 2021
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    CBK
    UDI-DI
    00606959015364
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE'S LCD SCREEN WAS FOUND TO BE CRACKED AND UNABLE TO BE VIEWED. THE LCD SCREEN WILL NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993410 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK PHILIPS RESPIRONICS INC. 1054260 00606959015364

    Patients

    Seq Age Sex Outcome Treatment
    1