BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIVE AED WITH AVIVE CONNECT

    MDR report key: 20263226 · Received September 19, 2024

    Report

    Report Number
    3026007685-2024-00007
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 2, 2024
    Report Date
    September 19, 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 EMAILED IN AND SAID THE PAD CARTRIDGE IS LOOSE AND WILL NOT "CLICK" INTO THE AED SIMILAR TO OTHER UNITS. THE CUSTOMER TRIED THE SAME PAD CARTRIDGE WITH ANOTHER AED AND IT WAS ABLE TO CLICK IN. CUSTOMER CONFIRMED THERE NO WIRES BLOCKING THE PAD CARTRIDGE FROM CLICKING IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225789 AVIVE AED WITH AVIVE CONNECT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ AVIVE SOLUTIONS, INC. 00860002508559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown