BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODE ONESTEP CPR A/A GC, SINGLE

    MDR report key: 16526424 · Received March 10, 2023

    Report

    Report Number
    1218058-2023-00056
    Event Type
    Death
    Date Received
    March 10, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 2, 2023
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRODES WERE RETURNED TO ZOLL MEDICAL UNITED KINGDOM FOR EVALUATION. EVALUATION OF THE ELECTRODES REVEALED THAT THERE WAS AN EXCESSIVE AMOUNT OF HAIR ATTACHED TO THE GEL. THE ELECTRODES PASSED CONTINUITY TESTING. THE LOGS FROM THE EVENT WERE NOT PROVIDED. BASED ON THE CUSTOMER'S DESCRIPTION AND OBSERVED EXCESSIVE HAIR ON THE ELECTRODE, THIS CLAIM WILL BE CLOSED AS POOR COUPLING BETWEEN PATIENT AND ELECTRODE DUE TO POOR PATIENT PREPARATION. R SERIES OPERATOR'S GUIDE, PATIENT SAFETY, STATES: "EXCESSIVE BODY HAIR OR WET, DIAPHORETIC SKIN CAN INHIBIT ELECTRODE COUPLING TO THE SKIN. CLIP EXCESS HAIR AND DRY ANY MOISTURE FROM THE AREA WHERE AN ELECTRODE IS TO BE ATTACHED." ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 62-YEAR-OLD MALE PATIENT, A LOUD POP NOISE WAS HEARD ON DELIVERY OF THE THIRD SHOCK, ALONG WITH A WHITE FLASH AND SMOKE WERE SEEN FROM THE ELECTRODE PADS. THE PADS WERE THEN REMOVED TO REPLACE AND UPON REMOVAL, A BURN OF AN UNKNOWN DEGREE WAS SEEN ON THE PATIENT'S CHEST. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577235 ELECTRODE ONESTEP CPR A/A GC, SINGLE ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-000251-05 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Death