BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIVE AED WITH AVIVE CONNECT

    MDR report key: 20898429 · Received December 10, 2024

    Report

    Report Number
    3026007685-2024-00013
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    October 2, 2024
    Report Date
    December 10, 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 CALLED IN STATING HER AED HAD A RED STATUS LIGHT AND "FAILED AED SELF TEST" FOR THE SECOND TIME. FIRST TIME OCCURRED EARLY SEPTEMBER. CUSTOMER SERVICE WAS ABLE TO ASSIST THE CUSTOMER IN GETTING THE DEVICE BACK IN WORKING ORDER BUT TO CALL BACK IF THE ISSUE RECURRED. CUSTOMER CALLED AGAIN AND STATED THE DEVICE FAILED A SELF TEST AGAIN AND GIVES THE MESSAGE: "DEVICE CANNOT BE USED, MUST BEGIN CPR". UPON INVESTIGATION OF THE DEVICE, IT WAS DISCOVERED THAT THE DEVICE FAILED AN INTERNAL SELF-TEST AFTER IDENTIFYING A POTENTIALLY CORRUPTED AUDIO FILE. IN AN EMERGENCY, A CORRUPTED AUDIO FILE MAY NOT BE ABLE TO PLAY AUDIO PREVENTING THE AED FROM PROVIDING THE USER WITH CRITICAL LIFE SAVING OR SAFETY INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2576182 AVIVE AED WITH AVIVE CONNECT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ AVIVE SOLUTIONS, INC. 00860002508559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown