BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIVE AED WITH AVIVE CONNECT

    MDR report key: 20082289 · Received August 27, 2024

    Report

    Report Number
    3026007685-2024-00006
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 22, 2024
    Report Date
    August 27, 2024
    Manufacturer
    AVIVE SOLUTIONS, INC.
    Product Code
    MKJ
    UDI-DI
    00860002508559
    PMA / PMN Number
    P210015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AVIVE HAS REPORTED ALL INFORMATION AVAILABLE AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE END USER IN CHARGE OF MANAGING ALL AEDS FOR US MARSHALLS SERVICE DISCOVERED THIS AED WAS NOT POWERIN GON AFTER CHARGING FOR 24 HOURS. THERE WAS NO RESPONSE FROM THE AED WHEN THE POWER BUTTON WAS PRESSED, WHEN PROMPTED TO DO A STATUS CHECK AND WHEN THE PAD CARTRIDGE WAS REMOVED. ADDITIONALLY, THERE WERE NO BUTTONS OR LIGHTS FLASHING AT ANY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128068 AVIVE AED WITH AVIVE CONNECT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ AVIVE SOLUTIONS, INC. 00860002508559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown