BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 2030890 · Received March 23, 2011

    Report

    Report Number
    MW5019935
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 10, 2011
    Manufacturer
    MEDTRONIC PHYSIOCONTROL
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER CARDIAC CATH WAS PERFORMED, PATIENT DECOMPENSATED AND A CODE BLUE WAS CALLED. DEFIBRILLATOR/CODE CART BROUGHT TO BEDSIDE. EKG PATCHES APPLIED TO PATIENT AND ATTEMPTED TO TURN ON DEFIBRILLATOR TO EXTERNALLY PACE PATIENT. AFTER SEVERAL ATTEMPTS TO TURN ON DEFIBRILLATOR, IT WOULD NOT TURN ON WHILE ON BATTERY POWER. ANOTHER DEFIBRILLATOR WAS OBTAINED WHICH WAS SUCCESSFULLY POWERED ON. PATIENT WAS SUCCESSFULLY RESUSCITATED. OUR BIOMEDICAL STAFF WERE NOTIFIED OF THE DYSFUNCTION AND THEY RETRIEVED THE DEFIBRILLATOR AFTER THE CODE BLUE WAS RESOLVED. THE FAULTY DEFIBRILLATOR HAD BEEN CHECKED BY OUR STAFF EARLIER IN THE DAY AND BIOMED HAD PERFORMED PREVENTATIVE MAINTENANCE ON THE DEVICE EARLIER IN THE DAY. PER OUR BIOMED DEPARTMENT, POTENTIAL BATTERY FAILURE IS A KNOWN ISSUE WITH THE DEFIBRILLATOR AND THE MANUFACTURER HAD ISSUED A RECALL IN JUNE 2010, AND STATED A REPAIR WOULD BE IN PLACE WITHIN 9-12 MONTHS. OUR BIOMED DEPT HAS BEEN WAITING FOR A RESOLUTION FROM THE MANUFACTURER SINCE THIS RECALL. THE MANUFACTURER WAS NOTIFIED OF THIS EVENT AND THE INVOLVED DEFIBRILLATOR WAS REPAIRED ACCORDING TO THE RECOMMENDATIONS OF THE RECALL (WITH THE ASSISTANCE OF THE MANUFACTURER. SEVERAL OTHER DEFIBRILLATORS HAVE RECEIVED THE SAME REPAIR AS THEY WERE PART OF THE RECALL AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC LIFEPAK 20 DEFIBRILLATOR/MONITOR MKJ MEDTRONIC PHYSIOCONTROL 3202487-015

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening