BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK12

    MDR report key: 1090483 · Received July 31, 2008

    Report

    Report Number
    MW5007859
    Event Type
    Death
    Date Received
    July 31, 2008
    Date of Event
    November 30, 2007
    Report Date
    July 31, 2008
    Manufacturer
    PHYSIO-CONTROL
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING THE INVESTIGATION OF AN INCIDENT INVOLVING THE USE OF LIFEPAK DEFIBRILLATOR OUR CLINICAL ENGINEERING DEPT FOUND THAT THE LABELS ON THE EXTERNAL STERILIZABLE PADDLES TO HAVE BEEN REVERSED - APEX AND STERNUM-. WE DO NOT FEEL THAT THIS ERROR CONTRIBUTED TO THE OUTCOME OF THIS EVENT, HOWEVER, WOULD LIKE TO BRING IT TO YOUR ATTENTION. THE COMPANY HAS EVALUATED THE MACHINE AND THEY CONFIRMED THE LABELING ISSUE AND ARE WORKING TO IDENTIFY AFFECTED LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK12 DEFIBRILLATOR LDD PHYSIO-CONTROL LP12

    Patients

    Seq Age Sex Outcome Treatment
    1 Death