BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 635949 · Received September 14, 2005

    Report

    Report Number
    3015876-2005-00349
    Event Type
    Malfunction
    Date Received
    September 14, 2005
    Date of Event
    August 8, 2005
    Report Date
    August 15, 2005
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "DURING CODE PT NEEDED TO BE DEFIBRILLATED WAS IN V-FIB BI PHASIC DEFIBRILLATOR WOULD ONLY CHARGE TO 10 J X2. WITH HANDS FREE DEVICE. IT WOULD ALSO ONLY CHARGE TO 10 J WITH PADDLE. PT WAS SHOCKED WITH 10 J AND THEN DEFIB WAS CHARGED TO 360 J AND THE PT WAS SHOCKED AGAIN. THEY WERE CONVERTED TO SINUS RHYTHM THEN WENT BACK TO V-FIB THEN EMD 15 MINUTES LATER. MALFUNCTION DID NOT INFLUENCE OUTCOME. PT WAS IN ELECTRICAL STORM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR