BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIK-COMBO

    MDR report key: 2800887 · Received September 20, 2012

    Report

    Report Number
    2800887
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    April 17, 2012
    Report Date
    September 20, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    BURNING SMELL NOTED WITH SHOCK, DEFIB PADS FOUND TO BE THE CAUSE AND SWITCHED OUT.THERE WAS A DEFIBRILLATOR, HOWEVER THE DEFIBRILLATOR WAS OPERATING WITHOUT ISSUE. IT IS UNKNOWN IF ANY OTHER DEVICES CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIK-COMBO ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION MLN MEDTRONIC * 135707

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR