BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILLIPS

    MDR report key: 2110045 · Received May 18, 2011

    Report

    Report Number
    2110045
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 16, 2011
    Manufacturer
    PHILLIPS
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WENT INTO VENTRICULAR FIBRILLATION REQUIRING DEFIBRILLATION. PHILLIPS DEFIBRILLATOR USED IN CONJUNCTION WITH TYCO/KENDAL MEDITRACE 121OH MULTIFUNCTION ELECTRODE, WHICH WERE PLACED ON THE PATIENT'S CHEST ACCORDING TO MANUFACTURER RECOMMENDATION. THE PATIENT WAS DEFIBRILLATED AT 200 JOULES TWICE. ON THE THIRD DEFIBRILLATION (AT 200 JOULES) A SMALL ELECTRICAL ARC WAS NOTED TO ARC FROM THE MULTIFUNCTION ELECTRODE, TOWARD THE ECG ELECTRODE. THE ECG ELECTRODE WAS APPROXIMATELY 2CM IN DISTANCE FROM THE MULTIFUNCTION ELECTRODE. THE MULTIFUNCTION ELECTRODES WERE REMOVED, REPLACED WITH NEW ONES, AND PATIENT WAS DEFIBRILLATED SEVERAL MORE TIMES. NO OTHER ELECTRICAL ARC WAS NOTED. INSPECTION OF THE PATIENT'S SKIN UNDER THE MULTIFUNCTION ELECTRODE REVEALED BURN TO SKIN (RED AREA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILLIPS DEFIBRILLATOR MKJ PHILLIPS HEARTSTART M4735A-P

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention TYCO / KENDAL/ MEDITRACE 121OH MULTIFUNCTION| ELECTRODE: EXPIRATION DATE: NOVEMBER 2011