BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIVE AED WITH AVIVE CONNECT

    MDR report key: 23864208 · Received December 22, 2025

    Report

    Report Number
    3026007685-2025-00005
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 22, 2025
    Manufacturer
    AVIVE SOLUTIONS, INC.
    Product Code
    MKJ
    UDI-DI
    00860002508559
    PMA / PMN Number
    P210015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTED "WHEN I PULLED THE AED PADS FROM MY AVIVE AED, THEY NEVER ACTIVATED AND IT NEVER RECOGNIZED THAT I HAD APPLIED THEM. ANOTHER CARE TEAM MEMBER ARRIVED JUST AFTER ME SO WE USED ANOTHER AVIVE AED AND IT WORKED AND SHOCKED THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2256866 AVIVE AED WITH AVIVE CONNECT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ AVIVE SOLUTIONS, INC. 00860002508559

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown