BEUDAMED
    FDA Adverse Event Summary report: N

    ZOLL STAT PADZ

    MDR report key: 3143271 · Received March 12, 2013

    Report

    Report Number
    3143271
    Date Received
    March 12, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    DRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELECTIVE CARDIOVERSION DONE FOR PATIENT AT BEDSIDE BY CCM WITH ICU RN. PT CARDIOVERTED WITH 200 J, BUT AT THAT TIME A "POP" WAS HEARD, A BURN SMELL WAS EVIDENT IMMEDIATELY, AND UPON REMOVAL OF ANTERIOR PAD, A BURN APPROX 3" CIRCLE (SAME SIZE AND SHAPE AS THE CONDUCTIVE PORTION OF THE PAD) WAS NOTED ON PATIENT'S CHEST. PAD HAD BEEN NEAR THE INCISION, BUT ONLY THE STICKY PART WAS ON THE INCISION, AND THERE WERE NO STAPLES REMAINING AND NO OTHER METAL ON THE PATIENT'S CHEST AT ALL. ON CHECKING AFTER THE EVENT, PADS WERE FOUND TO HAVE BEEN PROPERLY AND COMPLETELY ADHERED TO THE PATIENT'S SKIN WITH NO WRINKLES AND NO AREAS THAT WERE NOT STUCK TO THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104521 ZOLL STAT PADZ ADULT ELECTRODES WITH HVP GEL DRX ZOLL MEDICAL CORP. 0313

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention ZOLL DDEFIBRILLATOR| ZOLL CARDIOVERTER