BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 6087127 · Received November 8, 2016

    Report

    Report Number
    2518422-2016-04464
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 2016
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959015364
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR HAD A FAILURE OF ITS INTERNAL BATTERY. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, ERROR CODES RELATED TO THE CHARGING OF THE INTERNAL BATTERY WERE OBSERVED. THE DEVICE'S INTERNAL BATTERY, POWER MANAGEMENT BOARD, AND SYSTEM BOARD WERE REPLACED TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738649 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260 00606959015364

    Patients

    Seq Age Sex Outcome Treatment
    1