BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIVE AED WITH AVIVE CONNECT

    MDR report key: 20624151 · Received November 6, 2024

    Report

    Report Number
    3026007685-2024-00010
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 7, 2024
    Report Date
    November 6, 2024
    Manufacturer
    AVIVE SOLUTIONS, INC.
    Product Code
    MKJ
    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 CALLED IN REGARDING A SYNCING ERROR ON THEIR AED. UPON PLUGGING IN THE AED TO CHARGE, THE LIGHT WAS FLASHING GREEN BUT DID NOT FLASH GREEN ONCE PER SECOND TO INDICATE CHARGING. ADDITIONALLY, THE CUSTOMER WAS UNABLE TO PERFORM A STATUS CHECK OR START AN EMERGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991924 AVIVE AED WITH AVIVE CONNECT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ AVIVE SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown