BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVIVE AED WITH AVIVE CONNECT

    MDR report key: 25136398 · Received May 11, 2026

    Report

    Report Number
    3026007685-2026-00005
    Event Type
    Injury
    Date Received
    May 11, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 11, 2026
    Manufacturer
    AVIVE SOLUTIONS, INC.
    Product Code
    MKJ
    UDI-DI
    00860002508559
    PMA / PMN Number
    P210015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PAD CARTRIDGE USED DURING THE EVENT WAS NOT RETURNED TO AVIVE FOR INVESTIGATION. TESTING WAS PERFORMED ON THE USED AED RETURNED TO AVIVE AND CONFIRMED THAT THE DEVICE CAN SUCCESSFULLY DETECT A PHYSIOLOGICAL PATIENT SIMULATOR AT THE NOMINAL, LOWER AND UPPER BOUND IMPEDANCES, ABLE TO CORRECTLY CLASSIFY SHOCKABLE OR NOT SHOCKABLE, AND ABLE TO DELIVER A SHOCK AT THE CORRECT ENERGY LEVEL WHEN TESTED WITH A NEW PAD CARTRIDGE. THERE WAS NO ISSUE FOUND WITH THE AED, THE AED PLAYED THE EXPECTED AUDIO INSTRUCTIONS CORRECTLY AND MET THE ESSENTIAL PERFORMANCE. REVIEW OF THE AED INCIDENT LOGS REVEALED THAT THE DEVICE DURING THE INCIDENT WAS SUCCESSFULLY POWERED ON, AND AUDIO INSTRUCTED THE USER TO PEEL AND PLACE THE PADS ON THE PATIENT. LOGS REVEALED THAT THE PATIENT IMPEDANCE WAS OUTSIDE OF THE ACCEPTABLE IMPEDANCE RANGE FOR THE ENTIRETY OF THE EVENT. THIS INDICATES THAT THE PADS WERE NOT MAKING PROPER CONNECTION TO THE PATIENT WHICH CAN OCCUR DUE TO HAIR ON PATIENT'S CHEST NOT SHAVED BEFORE PADS WERE PLACED AS REPORTED BY THE USER. LOG REVIEW OF THE INCIDENT INDICATED THAT THE AED WAS POWERED ON FROM A TRAY PULL AND THEN POWERED OFF USING THE POWER BUTTON 39 SECONDS LATER. THE USER REPORTED THAT ADDITIONAL STAFF MEMBERS PRESENT AT THE INCIDENT PEELED AND PREPARED THE PADS AFTER A TRAY PULL. A MOMENT AFTER THE PADS WERE PLACED, THE USER STATED THAT THE AED WAS NOT PLAYING STEP BY STEP AUDIO INSTRUCTIONS. BASED ON LOG REVIEW AND THE USER'S EVENT DESCRIPTION, ONE OF THE USERS LIKELY ACCIDENTALLY POWERED OFF THE AED USING THE POWER BUTTON WHICH LIKELY RESULTED IN THE USER NOT HEARING THE AED STEP BY STEP INSTRUCTIONS. THE USERS DID NOT ATTEMPT TO PRESS THE AED POWER BUTTON AGAIN AFTER THE DEVICE WAS POWERED OFF.

    Description of Event or Problem · 0

    THE USER REPORTED THAT ADDITIONAL STAFF MEMBERS PRESENT AT THE INCIDENT PEELED AND PREPARED THE PADS AFTER A TRAY PULL, WHILE THE USER PERFORMED CPR. THE USER REMOVED THE PATIENT'S CLOTHING AND APPLIED THE ELECTRODE PADS. THE USER STATED THAT THE PATIENT HAD A HAIRY CHEST AND WHILE A RAZOR WAS AVAILABLE IN A SEPARATE POUCH, THE USER WAS UNAWARE AT THE TIME THAT THE PATIENT'S CHEST NEEDED TO BE SHAVED. THE USER STATED THAT THE AED DIDN'T WORK AND THE ONLY AUDIBLE PROMPT THAT HE RECALLED HEARING FROM THE DEVICE WAS "POWERED ON". WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY DUE TO LIFE-SAVING THERAPY/TREATMENT MAY HAVE BEEN DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471256 AVIVE AED WITH AVIVE CONNECT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ AVIVE SOLUTIONS, INC. AED01 00860002508559

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male Life Threatening