BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4871378 · Received June 26, 2015

    Report

    Report Number
    2518422-2015-01814
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO CHARGE ITS INTERNAL BATTERY. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS OBSERVED IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE FAILED A STEP DURING TESTING. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416246 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1