BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1082781 · Received July 24, 2008

    Report

    Report Number
    3015876-2008-00829
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL REPLACED THE ADULT PADDLE ELECTRODE ASSEMBLY, LOT CODE 21005. PROCESS CHANGES TO INCREASE THE AMOUNT OF ADHESIVE TO THE ELECTRODE PLATE WERE IMPLEMENTED BEGINNING WITH LOT CODE 24443.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE ELECTRODE PLATE FROM THE DEVICE'S ADULT HARD PADDLE ADAPTER HAD SEPARATED FROM THE PADDLE ENCLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA