BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY CLARK

    MDR report key: 520697 · Received March 31, 2004

    Report

    Report Number
    MW1031733
    Event Type
    Malfunction
    Date Received
    March 31, 2004
    Date of Event
    March 16, 2004
    Report Date
    March 22, 2004
    Manufacturer
    *
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    TWO SETS OF KIMBERLY CLARK R2 PADS ARCING WHILE DELIVERING DEFIBRILLATION TO PT IN CARDIAC ARREST.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 5/20/04: MFR HAS THOROUGHLY CHECKED COMPLAINT FILES AND THE REFERENCED MEDWATCH REPORT, AND ALTHOUGH THE REPORT WAS SENT TO THE FDA, THE REPORT WAS NOT SENT TO KIMBERLY-CLARK CORP NOR WAS A RELATED COMPLAINT RECEIVED ON THIS PARTICULAR PRODUCT CODE AND LOT NUMBER. THEREFORE, PROVIDING SPECIFIC ANSWERS TO THE FOUR QUESTIONS POSED IN THE APRIL 23RD LETTER WILL NOT BE POSSIBLE. THE SUBECT MEDICAL DEVICE (R2 PADS) WAS MANUFACTURED BY BALLARD MEDICAL PRODUCTS (POCATELLO, ID) A WHOLLY OWNED SUBSIDIARY OF KIMBERLY-CLARK CORPORATION. THE 2,523 R2 PAD SETS WERE MANUFACTURED IN APRIL OF 2003 AND THE PRODUCT'S EXPIRATION DATE IS OCTOBER 2, 2004. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR LOT NUMBER 212784, ON MAY 10, 2004, AND ALL PRODUCTS MET THE MANUFACTURING SPECIFICATIONS. ON MAY 10, 2004 TESTING WAS PERFORMED ON TWO SETS OF RETAINED SAMPLES FROM STOCK CODE 3200-1715 AND LOT NUMBER 212784 (THE STOCK CODE GIVEN IN THE MEDWATCH REPORT, 3300-1715, WAS INCORRECT). BOTH SETS OF PADS WERE CHECKED FOR ELECTRICAL CONTINUITY USING A MULTIMETER. ELECTRICAL CONTINUITY WAS CONFIRMED ON BOTH SETS OF PADS. EACH PAD SET WAS THEN PLACED TOGETHER, GEL SIDE FACING IN. THE PAD SETS WERE THEN CONNECTED TO A CODE MASTER XL (HEWELETT PACKARD). BOTH SETS OF PADS WERE DISCHARGED AT 200, 300 AND 360 JOULES. ELECTRICAL ENERGY WAS DELIVERED EACH TIME WITH NO IRREGULARITIES OBSERVED INCLUDING NO ARCING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY CLARK R2 DEFIBRILLATION PADS MLN * 3300-1715 212784

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR