BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIVE AED WITH AVIVE CONNECT

    MDR report key: 20634177 · Received November 7, 2024

    Report

    Report Number
    3026007685-2024-00011
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    July 2, 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 WAS NOTIFIED OF A FAILED SELF-TEST AND THAT THE AED WAS UNOPERABLE. THE AED LIGHT WAS FLASHING RED. 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
    1952453 AVIVE AED WITH AVIVE CONNECT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ AVIVE SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown