BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODES, ONESTEP COMPLETE

    MDR report key: 5316319 · Received December 21, 2015

    Report

    Report Number
    1218058-2015-00151
    Event Type
    Death
    Date Received
    December 21, 2015
    Date of Event
    November 30, 2015
    Report Date
    December 3, 2015
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE ELECTRODE PADS WERE DISCARDED SUBSEQUENT TO THE PATIENT EVENT, THEREFORE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER HAD INDICATED THAT THE ELECTRODES WERE OPENED INCORRECTLY. THIS RESULTED IN A CONNECTION OF THE ELECTRODES TO THE PATIENT, WITH THE SHORTING WIRE TOUCHING THE PATIENT'S SKIN. THE CUSTOMER ACKNOWLEDGES THAT THE PADS WERE NOT OPENED CORRECTLY AND RECOGNIZES THEY SHOULD BE USING THE RED TABS TO OPEN THE PACKAGING. TREND ANALYSIS WAS PERFORMED AND NO EVIDENCE OF AN INCREASE IN TREND WAS FOUND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A (B)(6) MALE PATIENT, THE ELECTRODES WERE NOT OPENED CORRECTLY, RESULTING IN THE ELECTRODE SHORTING WIRE TO BE EXPOSED TO THE PATIENT'S SKIN. WHEN A DISCHARGE WAS GIVEN TO THE PATIENT, AN ARC WAS SEEN. COMPLAINANT INDICATED THAT THE WIRE WAS REMOVED AND TREATMENT TO THE PATIENT WAS CONTINUED. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841032 ELECTRODES, ONESTEP COMPLETE ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0224-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death