BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIVE AED WITH AVIVE CONNECT

    MDR report key: 19610820 · Received June 25, 2024

    Report

    Report Number
    3026007685-2024-00004
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    June 21, 2024
    Report Date
    June 25, 2024
    Manufacturer
    AVIVE SOLUTIONS, INC.
    Product Code
    MKJ
    UDI-DI
    00860002508559
    PMA / PMN Number
    P210015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING DEVICE SET-UP, THE USER NOTICED THE AED POWER BUTTON DID NOT REACT WHEN PROMPTING A STATUS CHECK. THE DEVICE REMAINED UNRESPONSIVE AFTER TROUBLESHOOTING WITH THE DEVICE UNPLUGGED AND NO INDICATOR LIGHT WAS PRESENT ON THE DEVICE. LOGS SHOW THE AED HAD SUFFICIENT BATTERY ON AED WAS SHOWING ADEQUATE BATTERY POWER IN REAL CONNECT. WHEN PLUGGED INTO POWER: THE BUTTONS ON TOP OF AED WERE RESPONSIVE TO PRESSES AND THE INDICATOR LIGHT WAS BLINKING RED. ADDITIONALLY, THE DEVICE AUDIO WAS SCRATCHY WHEN POWER BUTTON WAS PRESSED.

    Description of Event or Problem · 0

    USER ADAM PENN DISCOVERED THE ALLEGED MALFUNCTION WHEN HE WAS DEMONSTRATING DURING A TRAINING SESSION ON (B)(6). WHEN HE PRESSED THE WHITE AED POWER BUTTON AS WELL AS PULLED RED TAB - THERE WAS NO REACTION FROM THE THE AED. HE CHARGED THE AED OVERNIGHT - AND WAS STILL EXPERIENCING THE SAME NON RESPONSE FROM THE AED. OVER THE PHONE - I HAD ADAM PLUG THE AED IN AND PROMPT A STATUS CHECK - THERE WAS NO REACTION FROM THE AED. THE LIGHT WAS NOT DISPLAYING FLASHING OR COLOR OF ANY KIND.

    Description of Event or Problem · 0

    THE USER DISCOVERED THE ALLEGED MALFUNCTION WHEN HE WAS DEMONSTRATING DURING A TRAINING SESSION ON 6/21. THERE WAS NO REACTION FROM THE AED WHEN HE PRESSED THE WHITE AED POWER BUTTON AS WELL AS PULLED RED TAB - THERE WAS NO REACTION FROM THE THE AED. HE CHARGED THE AED OVERNIGHT - AND WAS STILL EXPERIENCING THE SAME NON RESPONSE FROM THE AED. OVER THE PHONE - I HAD ADAM PLUG THE AED IN AND PROMPT A STATUS CHECK - THERE WAS NO REACTION FROM THE AED. THE LIGHT WAS NOT DISPLAYING FLASHING OR COLOR OF ANY KIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807281 AVIVE AED WITH AVIVE CONNECT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ AVIVE SOLUTIONS, INC. 00860002508559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown