BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LIFE PAK 20

    MDR report key: 1812219 · Received August 18, 2010

    Report

    Report Number
    MW5017156
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 29, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CODE, THE DEFIBRILLATOR MALFUNCTIONED DURING A CODE. PER STAFF, THE DEFIBRILLATOR WAS OPERATING NORMALLY DURING THE CHECKS ON THE PREVIOUS SHIFT. WHEN THE CODE WAS CALLED, THE DEFIBRILLATOR WAS UNPLUGGED AND TAKEN TO THE ROOM. THE RN TURNED ON THE MACHINE WHICH FLASHED INFO ON THE SCREEN THEN SHUT ITSELF DOWN. SHE TRIED AGAIN WITH THE SAME RESULT. THINKING IT WAS THE BATTERY, THE DEFIBRILLATOR WAS PLUGGED IN AND IT WAS TRIED TWICE MORE WITH THE SAME RESULT. ANOTHER DEFIBRILLATOR WAS OBTAINED. THE DEFIBRILLATOR IN QUESTION WAS GIVEN TO BIOMEDICAL STAFF. THEY COULD NOT REPLICATE THE PROBLEM, AND IT DID NOT APPEAR TO BE USER ERROR. IT WAS SENT BACK TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC LIFE PAK 20 DEFIBRILLATOR-CARDIOSCOPE MKJ MEDTRONIC, INC. LIFE PAK 20

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Life Threatening