BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIVE AED WITH AVIVE CONNECT

    MDR report key: 20736880 · Received November 20, 2024

    Report

    Report Number
    3026007685-2024-00012
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    October 22, 2024
    Report Date
    November 20, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION WAS CONDUCTED AND IT WAS OBSERVED THERE WAS RESIDUE ON THE PCBAS AND HOUSINGS. THE RESIDUE IS MOST LIKELY DUE TO LIQUID DAMAGE AS A RESULT OF USER MISHANDLING.

    Description of Event or Problem · 0

    CUSTOMER CALLED IN SAYING THEIR AED WILL NOT CHARGE. THEY HAD IT PLUGGED IN FOR ABOUT TWO WEEKS. THE SCREEN DOES NOT TURN ON AND THE AED DOES NOT TURN ON EITHER. WHEN THE CUSTOMER PLUGGED IN THE DEVICE, THE AED FLASHED RED FOR A SECOND. UPON UNPLUGGING AND REPLUGGING IN, THE DEVICE DID NOT FLASH. ADDITIONALLY, THE AED WAS UNRESPONSIVE WHEN PERFORMING A STATUS CHECK.

    Description of Event or Problem · 0

    CUSTOMER CALLED IN SAYING THEIR AED WILL NOT CHARGE. THEY HAD IT PLUGGED IN FOR ABOUT TWO WEEKS. THE SCREEN DOES NOT TURN ON AND THE AED DOES NOT TURN ON EITHER. WHEN THE CUSTOMER PLUGGED IN THE DEVICE, THE AED FLASHED RED FOR A SECOND. UPON UNPLUGGING AND REPLUGGING IN, THE DEVICE DID NOT FLASH. ADDITIONALLY, THE AED WAS UNRESPONSIVE WHEN PERFORMING A STATUS CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2460369 AVIVE AED WITH AVIVE CONNECT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ AVIVE SOLUTIONS, INC. 00860002508559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown