BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE STEP COMPLETE ELECTRODES

    MDR report key: 7003047 · Received November 6, 2017

    Report

    Report Number
    1218058-2017-00117
    Event Type
    Death
    Date Received
    November 6, 2017
    Date of Event
    October 10, 2017
    Report Date
    October 16, 2017
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE ELECTRODE PADS AND THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE ELECTRODE PADS WERE PUT THROUGH EXTENSIVE TESTING SIMULATING 2015 AHA GUIDELINES AT VARIOUS LENGTHS OF TIME WITH THE ELECTRODES ATTACHED TO A MANIKIN IN CONFIGURATIONS IDENTIFIED IN THE IFU. THE TEST WAS REPEATED MULTIPLE TIMES WITH DIFFERENT PERSONAL APPLYING THE ELECTRODES ALONG WITH VARYING SKIN PREPARATIONS. EVALUATION OF THE ELECTRODES DID NOT REVEAL ANY IRREGULARITIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IT IS NOTEWORTHY TO MENTION THE CUSTOMER'S RISK MANAGER, CNO, AND AMET PROGRAM COORDINATOR WERE INVOLVED IN THE INVESTIGATION AND INFORMED OF OUR FINDINGS. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) MALE PATIENT, THE ELECTRODES WOULD NOT ADHERE TO THE PATIENT'S SKIN AND THE ASSOCIATED DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODES TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, UNKNOWN IF IT WAS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784568 ONE STEP COMPLETE ELECTRODES ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0224-01 0617 00847946016272

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death