BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART

    MDR report key: 2132142 · Received June 13, 2011

    Report

    Report Number
    2132142
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 13, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS A MOCK CODE ON A SIMULATION MANIKIN. A PHILIPS MRX MONITOR/DEFIBRILLATOR WAS USED TO SHOCK THE MANIKIN USING PHILLIPS ADULT DEFIBRILLATOR PADS (ELECTRODES). THE MRX DEFIBRILLATOR WAS PLACED IN THE AED MODE TO SHOCK AN ARREST. "SHOCK ADVISED" WAS ANNOUNCED FROM THE MRX DEFIBRILLATOR. THEN THE AED SAYS TO PRESS THE ORANGE BUTTON. THE DEFIBRILLATOR STATED THE "SHOCK NOT DELIVERED." OPENED A NEW SET OF AED PADS. TRIED SAME PROCEDURE TWICE WITH SAME RESULTS. FOR THE NEXT MOCK CODE, WE USED A SET OF COMPETITOR'S ADULT PADS (DEFIBRILLATOR ELECTRODES) AND HAD NO ISSUES. RETESTED THE SAME PHILIPS PADS LATER IN THE DAY AND RECEIVED "SHOCK NOT DELIVERED," RESULT AGAIN.MANUFACTURER RESPONSE FOR ELECTRODES, DEFIBRILLATOR, MULTIFUNCTION, HEARTSTART: NONE AS OF YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART ELECTRODE, DEFIBRILLATOR, MULTIFUNCTION MKJ PHILIPS MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *