BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 581111 · Received June 14, 2004

    Report

    Report Number
    3015876-2004-00228
    Event Type
    Malfunction
    Date Received
    June 14, 2004
    Date of Event
    May 18, 2004
    Report Date
    May 18, 2004
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PARAMEDICS RESPONDED TO A PERSON, CONDITION UNKNOWN. THE PT WAS CONNECTED TO THE DEVICE WITH ECG ELECTRODES THEN PREPPED FOR EXTERNAL PACING WITH THE DEVICE, CONNECTING DISPOSABLE PACING/DEFIBRILLATION/ECT ELECTRODES TO THE PT AND THE DEVICE. ACCORDING TO THE REPORTER, THE DEVICE STOPPED PACING ON ITS OWN AN UNKNOWN NUMBER OF TIMES AT THE SCENE AND HAD TO BE MANUALLY RESTARTED EACH TIME. DURING TRANSPORT, THE PT ARRESTED AND THE DEVICE WAS USED TO DEFIBRILLATE THEM. THE PT'S RHYTHM CONVERTED AND THEN TRANSPORTED TO THE HOSP. PT OUTCOME IS UNKNOWN.

    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 12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR P/N 3010188-011, D/C UNK, 2004.| EDGE SYSTEM ELECTRODES WITH QUIK-COMBO CONNECTOR,