BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODES, ONESTEP CPR, SINGLE, R SERIES

    MDR report key: 12063139 · Received June 24, 2021

    Report

    Report Number
    1218058-2021-00080
    Event Type
    Death
    Date Received
    June 24, 2021
    Report Date
    June 3, 2021
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE ASSOCIATED DEFIBRILLATOR INVOLVED AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING SHOCK TESTING WITHOUT DUPLICATING ANY MALFUNCTION TO THE DEVICE. THE ELECTRODE PADS FROM THE REPORTED EVENT WERE DISPOSED OF AND NOT AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE LOG CONFIRMED THE CUSTOMER'S REPORT. THE LOG SHOWED A SIGNIFICANT DIFFERENCE BETWEEN PATIENT AND DEFIB IMPEDANCE MEASUREMENTS DURING THE SEVENTH SHOCK. THIS IS AN INDICATION OF POOR COUPLING BETWEEN THE PATIENT AND ELECTRODES. IT IS IMPORTANT TO NOTE THAT THE ELECTRODE INSTRUCTION FOR USE WARNS USERS THAT POOR ADHERENCE OF THE ELECTRODES COULD LEAD TO THE POSSIBILITY OF ARCING AND SKIN BURNS. ADDITIONALLY, THE R SERIES OPERATORS GUIDE WARNS USERS AGAINST USING R SERIES PRODUCTS IN OXYGEN RICH ENVIRONMENTS AS IT COULD CAUSE AN EXPLOSION. THIS REPORT HAS BEEN ATTRIBUTED TO POOR COUPLING OF THE ELECTRODE PADS TO THE PATIENT'S SKIN. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6)-YEAR-OLD MALE PATIENT, AFTER THE 6TH SHOCK AN ARC/FIRE WAS SEEN ON THE PATIENT'S CHEST FROM THE ELECTRODE PADS. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953097 ELECTRODES, ONESTEP CPR, SINGLE, R SERIES ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0223-01 UNK 00847946016265

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death