BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 278724 · Received May 16, 2000

    Report

    Report Number
    3015876-2000-00247
    Event Type
    Malfunction
    Date Received
    May 16, 2000
    Date of Event
    February 22, 2000
    Report Date
    April 10, 2000
    Manufacturer
    MEDTRONIC PHYSIO-CONTROL CORP.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER MEDWATCH 39-0195-2000-0005: "DEFIBRILLATOR MALFUNCTIONED DURING A CARDIOVERSION PROCEDURE IN "EP" LABORATORY ON 02/22/2000. DEFIB FAILED TO DISCHARGE WHEN THE BUTTON WAS PRESSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER EXTERNAL DC DEFIBRILLATOR/CARDIAC MONITOR/TRANSCUTANEOUS PAC LDD MEDTRONIC PHYSIO-CONTROL CORP. 9P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR