BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIVE AED WITH AVIVE CONNECT

    MDR report key: 20626035 · Received November 6, 2024

    Report

    Report Number
    3026007685-2024-00009
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 1, 2024
    Report Date
    November 6, 2024
    Manufacturer
    AVIVE SOLUTIONS, INC.
    Product Code
    MKJ
    UDI-DI
    00860002508559
    PMA / PMN Number
    P210015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER'S AED BATTERY IS DYING FAST AND NOT HOLDING A CHARGE AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132345 AVIVE AED WITH AVIVE CONNECT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ AVIVE SOLUTIONS, INC. 00860002508559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown