BEUDAMED
    FDA Adverse Event Summary report: N

    LIFEPAK 12 AND LIFEPAK 20

    MDR report key: 1081155 · Received July 9, 2008

    Report

    Report Number
    1081155
    Date Received
    July 9, 2008
    Date of Event
    May 1, 2008
    Report Date
    July 9, 2008
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS
    Product Code
    MKJ
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    RN DESCRIPTION OF INCIDENT: DURING CARDIOVERSION, THE DEFIBRILLATOR ON THE CRASH CART WOULD NOT CHARGE COMPLETELY AND WOULDN'T RELEASE SHOCK. IT STARTED TO CHARGE BUT WOULDN'T COMPLETE THE CHARGE. A SECOND DEFIBRILLATOR WAS BROUGHT IN AND THE SAME THING HAPPENED, ALTHOUGH IT DID CHARGE AND SHOCK ONCE. A THIRD DEFIBRILLATOR WAS BROUGHT IN AND IT WORKED FINE. BOTH MONITORS WERE IN SYNC MODE AT THE TIME. CPD PICKED UP CRASH CART DEFIBRILLATOR. BIOMED PICKED UP THE LIFEPAK 12 DEFIBRILLATOR. MDS IN ROOM AT TIME. CLINICAL ENGINEERING EVALUATION: BIOMED INVESTIGATED THE 2 MACHINES AND FOUND NOTHING WRONG WITH THE MACHINES THEMSELVES. THIS WAS DETERMINED TO BE A USE ERROR. BIOMED STATED THAT THE VERBAL REPORT WAS THAT A MEDTRONIC LIFEPAK 12 WAS TRIED FIRST, THEN A LIFEPAK 20. THE USER FOLLOWED THE INCORRECT SEQUENCE OF EVENTS TO PROGRAM THE DEFIBRILLATORS. THE CORRECT SEQUENCE IS TO: 1. PRESS "ENERGY SELECT" TO CHOOSE ENERGY LEVEL 2. PRESS "CHARGE" 3. PRESS "SHOCK". INSTEAD, THE USER PRESSED "CHARGE", THEN "ENERGY SELECT." AT THIS POINT THE DEFIBRILLATOR WILL RESET ITSELF TO ZERO (WITH NO ON-SCREEN NOTIFICATION THAT IT HAS DONE SO), AND WILL NOT SHOCK. EDUCATION IS RECOMMENDED TO NEW USERS OF THE DEFIBRILLATORS. ANOTHER OPTION IS TO MAKE STICKERS WITH DIRECTIONS ON HOW TO PROGRAM THE DEFIBRILLATORS, AND PLACE THEM ON THE MACHINES. ALSO I RECOMMEND THAT THE MANUFACTURER, MEDTRONIC, GENERATE SOME KIND OF WARNING ON THE SCREEN WHEN IT RESETS, FOR FUTURE MODELS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 AND LIFEPAK 20 DEFIBRILLATOR MKJ MEDTRONIC EMERGENCY RESPONSE SYSTEMS LIFEPAK 12 *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR