BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRATION 5I VENTILATOR SYSTEM

    MDR report key: 4234276 · Received October 2, 2014

    Report

    Report Number
    3006135941-2014-00005
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    August 11, 2014
    Report Date
    October 2, 2014
    Manufacturer
    EVENT MEDICAL LTD.
    Product Code
    CBK
    PMA / PMN Number
    K130178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    UNIT SUDDENLY TURNED OFF AND SMOKE COMING OUT FROM THE BACK OF THE MACHINE, WE CAN SMELL SOMETHING IS BURN INSIDE. UNIT CAN BE TURNED BACK AFTER A WHILE, BATTERY WON'T CHARGE. WE FOUND SOME PARTS BURN ON THE POWER BOARD. THE UNIT IS BEING USED BEFORE WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614671 INSPIRATION 5I VENTILATOR SYSTEM CONTINUOUS VENTILATOR CBK EVENT MEDICAL LTD. 5I

    Patients

    Seq Age Sex Outcome Treatment
    1