BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 1290977 · Received January 15, 2009

    Report

    Report Number
    8020045-2009-00001
    Event Type
    Injury
    Date Received
    January 15, 2009
    Date of Event
    December 21, 2008
    Report Date
    January 15, 2009
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    ODR
    PMA / PMN Number
    K072233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED AND RETURNED SAMPLES OF THE SAME LOT HAVE BEEN TESTED VISUALLY, ELECTRICALLY AND ON THEIR ADHESION. ALL SAMPLES WERE FOUND TO PERFORM WITHIN THE LIMITS. NO FAULTS COULD BE DETECTED. THE DEVICE INVOLVED IN THE INCIDENT WAS DISCARDED AT THE MORGUE AS THE CORONER'S OFFICE CONCLUDED THAT THE DEVICE DID NOT CONTRIBUTE TO OR CAUSE THE DEATH AND THEREFORE DID NOT NEED TO BE RETAINED. ACCORDING TO AMBULANCE, IT IS POSSIBLE THAT THE DEFIBRILLATION PAD WAS NOT IN COMPLETE CONTACT WITH THE PATIENT'S SKIN, BECAUSE THE SCENE WAS DARK. THIS COULD HAVE LED TO ARCING, WHICH COULD CAUSE BURNS EXACTLY AS OBSERVED. AS NEITHER IMAGES OF THE WOUNDS INDICATING THEIR SIZE AND DISTRIBUTION NOR THE DEVICE INVOLVED WERE AVAILABLE FOR ANALYSIS, WE CONCLUDE THAT ARCING IS THE MOST LIKELY CAUSE FOR THE BURNS. ARCING CAN OCCUR WHEN A DEFIBRILLATION ELECTRODE IS NOT IN FULL CONTACT WITH THE SKIN. WHETHER THE ELECTRODE WAS NOT IN COMPLETE CONTACT INITIALLY OR LIFTED PARTIALLY DURING THE PROCEDURE DUE TO HAIR, SWEAT OR OTHER SUBSTANCES PRESENT ON THE CHEST, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    AMBULANCE WAS CALLED TO PATIENT IN CARDIAC ARREST. THE UNIT ARRIVED AT SITE THREE MINUTES AFTER THE CALL. THE SITE WAS DARK, THE PATIENT DIAPHORETIC. DUE TO THE CRITICAL CONDITION OF THE PATIENT, NO SKIN PREPARATION WAS CONDUCTED. THE PATIENT WAS DEFIBRILLATED TWICE, AT 200J AND AT 300J. A SKINTACT DF20 DEFIBRILLATION ELECTRODE AND PHYSIOCONTROL LIFE-PAK 12 DEFIBRILLATOR WAS USED. THE ELECTRODES WERE IN PLACE FOR APPROX 1 MINUTE PRIOR TO INITIAL DEFIBRILLATION AND STAYED ON THE PATIENT THROUGHOUT TREATMENT AND TRANSPORT. THE LIFE SAVING PROCEDURE WAS NOT SUCCESSFUL; THE PATIENT WAS PRONOUNCED DEAD AT THE HOSPITAL. A TOXICOLOGY ANALYSIS IS CURRENTLY BEING PERFORMED TO CHECK THE CORONER'S OFFICE SUSPICION THAT THE CARDIAC ARREST WAS THE RESULT OF A DRUG OVERDOSE. AFTER THE DEFIBRILLATION, THE PAD LOCATED TO THE RIGHT OF THE PATIENT'S STERNUM WAS OBSERVED TO HAVE FOLDED UP ONTO ITSELF FORMING A TENT LIKE SHAPE. THE PATIENT HAD SUFFERED 2ND AND 3RD DEGREE BURNS TO HIS CHEST ABOVE AND UNDER THIS PAD. A STRONG SMELL OF BURNT FLESH WAS PRESENT IN THE ROOM. THE CORONER'S OFFICE ADVISED THE EMS THAT THE DEFIBRILLATION PADS DID NOT PLAY A ROLE IN THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKINTACT GROUNDING PLATE ODR LEONHARD LANG GMBH DF20 80506-0771

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other