BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 5233841 · Received November 18, 2015

    Report

    Report Number
    2518422-2015-03903
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    November 12, 2015
    Report Date
    November 12, 2015
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959015364
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, "VENTILATOR INOPERATIVE" AND "SERVICE REQUIRED" CODES WERE OBSERVED IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BULK CAPACITOR, SENSOR BOARD, THERMISTOR, INTERNAL BATTERY, POWER MANAGEMENT BOARD AND DETACHABLE BATTERY CABLE WERE REPLACED TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764483 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260 00606959015364

    Patients

    Seq Age Sex Outcome Treatment
    1