BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED

    MDR report key: 19852514 · Received July 26, 2024

    Report

    Report Number
    MW5157728
    Event Type
    Death
    Date Received
    July 26, 2024
    Date of Event
    March 17, 2023
    Report Date
    July 24, 2024
    Manufacturer
    DEFIBTECH LLC.
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) WAS RUNNING ON THE TREADMILL AT (B)(6). HE WENT INTO CARDIAC ARREST AND THEY TRIED TO USE AN AED (AUTOMATED EXTERNAL DEFIBRILLATOR) ON HIM BUT IT FAILED TO ADMINISTER A LIFE-SAVING SHOCK AND (B)(6) WAS PRONOUNCED DECEASED ONCE HE ARRIVED AT (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384506 AED AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ DEFIBTECH LLC. DDU-100B

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Hospitalization| D