BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVIVE AED WITH AVIVE CONNECT

    MDR report key: 23658970 · Received November 26, 2025

    Report

    Report Number
    3026007685-2025-00004
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 16, 2025
    Report Date
    January 16, 2026
    Manufacturer
    AVIVE SOLUTIONS, INC.
    Product Code
    MKJ
    UDI-DI
    00860002508559
    PMA / PMN Number
    P210015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE AND PAD CARTRIDGE WERE NOT RETURNED TO AVIVE FOR INVESTIGATION. INVESTIGATION OF THE AED LOGS REVEALED THAT THE DEVICE WAS SUCCESSFULLY POWERED ON, AND AUDIO INSTRUCTED THE USER TO PEEL AND PLACE THE PADS ON THE PATIENT. LOGS INDICATED THAT THE DEVICE THEN STARTED TO TAKE IMPEDANCE READINGS, WHICH FELL BETWEEN 445-493 OHMS. AN IMPEDANCE VALUE IN THE ACCEPTABLE THRESHOLD FALLS BETWEEN 25 AND 200 OHMS. THE IMPEDANCE VALUES MEASURED BY THE DEVICE FELL ABOVE THE ACCEPTABLE THRESHOLD RANGE FOR ECG ANALYSIS AND SHOCK DELIVERY, AND THE DEVICE CORRECTLY IDENTIFIED THIS AND PLAYED AUDIO TO INSTRUCT THE USER TO CHECK THE PADS. THIS CAN BE DUE TO SEVERAL FACTORS SUCH AS IMPROPER PAD PLACEMENT / ADHERENCE, DEBRIS ON THE PADS, CLOTHING INTERFERENCE, OR BODY SURFACE CONDITIONS SUCH AS WET SKIN OR BODY HAIR. BASED ON THE USER'S DESCRIPTION OF THE EVENT, IT IS LIKELY THAT PATIENT BODY HAIR INTERFERED WITH THE PROPER ADHERENCE OF THE ELECTRODE PADS. BEFORE THE EVENT, THE DEVICE PASSED ALL DAILY, WEEKLY, AND MONTHLY SELF-TESTS. THERE WAS NO DEFICIENCY, MALFUNCTION, OR ERROR IDENTIFIED WITH THE AED DEVICE. THE EVENT IS REPORTED AS SERIOUS INJURY BECAUSE LIFE-SAVING THERAPY/TREATEMENT MAY HAVE BEEN INTRRUPTED/DELAYED. THE EVENT DATE IS CORRECTED TO (B)(6) 2025 BASED ON THE INFORMATION FORM THE CUSTOMER.

    Description of Event or Problem · 0

    CUSTOMER ATTEMPTED TO USE AVIVE AED DEVICE IN AN EMERGENCY BUT WERE HAVING TROUBLE WITH THE PAD CARTRIDGE. USER REPORTED THAT THE PAD CARTRIDGE WAS RECOGNIZED BY THE AED AND WALKED THEM UP TO THE "PLACE PADS ON PATIENT" STEP BUT THE PADS WOULD NOT TAKE A READING ON THE PATIENT AS THEY DID NOT SHAVE THE PATIENT AND THE PADS WERE NOT COMING IN CONTACT WITH SKIN. EMS ARRIVED ON SCENE BEFORE A READING COULD BE TAKEN AND TOOK OVER FROM THERE. STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 0

    CUSTOMER ATTEMPTED TO USE AVIVE AED DEVICE IN AN EMERGENCY BUT WERE HAVING TROUBLE WITH THE PAD CARTRIDGE. USER REPORTED THAT THE PAD CARTRIDGE WAS RECOGNIZED BY THE AED AND WALKED THEM UP TO THE "PLACE PADS ON PATIENT" STEP BUT THE PADS WOULD NOT TAKE A READING ON THE PATIENT AS THEY DID NOT SHAVE THE PATIENT AND THE PADS WERE NOT COMING IN CONTACT WITH SKIN. EMS ARRIVED ON SCENE BEFORE A READING COULD BE TAKEN AND TOOK OVER FROM THERE. STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2813167 AVIVE AED WITH AVIVE CONNECT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ AVIVE SOLUTIONS, INC. 00860002508559

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Life Threatening