BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR MONITOR SERIES

    MDR report key: 740167 · Received July 19, 2005

    Report

    Report Number
    3015876-2005-00262
    Event Type
    Malfunction
    Date Received
    July 19, 2005
    Date of Event
    May 14, 2005
    Report Date
    June 23, 2005
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    H6: DEVICE EVENT RECORD OF PATIENT'S ECG FROM THE REPORTED INCIDENT WAS ANALYZED WITH ENGINEERING TEST SHOCK ADVISORY SYSTEM (SAS) SOFTWARE TO DETERMINE IF DEVICE PROPERLY ANALYZED RHYTHM. ENGINEERING TEST RESULTS DETERMINED THE DEVICE'S SAS ANALYSIS OF THE PATIENT'S ECG OPERATED PROPERLY.

    Description of Event or Problem · 1

    EMT'S RESPONDED TO A PATIENT IN CARDIAC ARREST. THE DEVICE WAS CONNECTED TO THE PATIENT WITH DISPOSABLE DEFIBRILLATION/ECG ELECTRODES AND USED IN AED MODE. THE DEVICE ADVISED 6 SHOCKS THAT WERE DELIVERED. THE REPORTER STATED THE PATIEN'S RHYTHM CONVERTED AND MONITOR DISPLAYED A SINUS RHYTHM, BUT THEN THE DEVICE CONTINUED WITH ANOTHER ANALYSIS THAT DETERMINED THE RHYTHM WAS SHOCKABLE AND INITIATED A CHARGE. THE OPERATOR POWERED DOWN THE DEVICE TO DUMP THE CHARGE. THE PATIENT WAS RESUSCIATED. THE REPORTER IS QUESTIONING THE LAST RHYTHM ANALYSIS DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR MONITOR SERIES EXTERNAL DC DEFIBRILLATOR CARDIAC MONITOR MKJ MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. 12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR