BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4973352 · Received August 5, 2015

    Report

    Report Number
    2518422-2015-02264
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    RESPIRONICS, INC
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516288 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC 1054097

    Patients

    Seq Age Sex Outcome Treatment
    1