BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIVE AED WITH AVIVE CONNECT

    MDR report key: 19610819 · Received June 25, 2024

    Report

    Report Number
    3026007685-2024-00003
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    April 29, 2024
    Report Date
    June 25, 2024
    Manufacturer
    AVIVE SOLUTIONS, INC.
    Product Code
    MKJ
    PMA / PMN Number
    P210015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 WAS SCRATCHY WHEN POWER BUTTON WAS PRESSED.

    Description of Event or Problem · 0

    THE USER WAS GOING THROUGH A LARGE NUMBER OF THEIR AEDS, ONE BY ONE, AND CONNECTING TO THEIR NEW DEDICATED WI-FI NETWORK. THE USER NOTICED THE AED POWER BUTTON DID NOT REACT WHEN PRESS AND HOLDING FOR 5 SECONDS TO PROMPT A STATUS CHECK. THE USER AND I HAD OUR PERIODIC CHECKING VIDEO CALL AND THEY BROUGHT THE UNRESPONSIVE POWER BUTTON TO MY ATTENTION. I ASKED THEM TO PRESS ALL THE PHYSICAL BUTTONS (SPANISH, POWER, CHILD) ON TOP OF THE AED - AND ALL WERE UNRESPONSIVE WHEN PRESSED. THIS IS WITH THE AED UNPLUGGED. NO LIGHT WAS PRESENT. BATTERY ON AED WAS SHOWING ADEQUATE BATTERY POWER IN REAL CONNECT. WHEN PLUGGED INTO POWER: THE 3 BUTTONS ON TOP OF AED WERE RESPONSIVE TO PRESSES. LIGHT WAS BLINKING RED. AUDIO WAS SCRATCHY SOUNDING WHEN POWER BUTTON WAS PRESSED.

    Description of Event or Problem · 0

    THE USER WAS GOING THROUGH A LARGE NUMBER OF THEIR AEDS, ONE BY ONE, AND CONNECTING TO THEIR NEW DEDICATED WI-FI NETWORK. THE USER NOTICED THE AED POWER BUTTON DID NOT REACT WHEN PRESS AND HOLDING FOR 5 SECONDS TO PROMPT A STATUS CHECK. THE USER AND I HAD OUR PERIODIC CHECKIN VIDEO CALL AND THEY BROUGHT THE UNRESPONSIVE POWER BUTTON TO MY ATTENTION. I ASKED THEM TO PRESS ALL THE PHYSICAL BUTTONS (SPANISH, POWER, CHILD) ON TOP OF THE AED - AND ALL WERE UNRESPONSIVE WHEN PRESSED. THIS IS WITH THE AED UNPLUGGED. NO LIGHT WAS PRESENT. BATTERY ON AED WAS SHOWING ADEQUATE BATTERY POWER IN REALCONNECT. WHEN PLUGGED INTO POWER: THE 3 BUTTONS ON TOP OF AED WERE RESPONSIVE TO PRESSES. LIGHT WAS BLINKING RED. AUDIO WAS SCRATCHY SOUNDING WHEN POWER BUTTON WAS PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807280 AVIVE AED WITH AVIVE CONNECT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ AVIVE SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown