BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIVE AED WITH AVIVE CONNECT

    MDR report key: 21832245 · Received April 12, 2025

    Report

    Report Number
    3026007685-2025-00003
    Event Type
    Malfunction
    Date Received
    April 12, 2025
    Date of Event
    September 9, 2024
    Report Date
    August 19, 2025
    Manufacturer
    AVIVE SOLUTIONS, INC.
    Product Code
    MKJ
    PMA / PMN Number
    P210015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER INITIALLY REPORTED THAT THIS DEVICE WAS NOT ABLE TO DETECT A PATIENT IN A PAST EMERGENCY ON (B)(6) 2024. INVESTIGATION OF THE DEVICE LOGS ON (B)(6) 2024 CONFIRMED THE USER'S OBSERVATION THAT THE AED PLAYED THE AUDIO "PLACE THE PADS ON THE PATIENT." FROM THE LOG REVIEW, IT WAS REVEALED THAT THE PATIENT IMPEDANCE WAS OUTSIDE OF THE ACCEPTABLE IMPEDANCE RANGE FOR MOST OF THE EVENTS. MOST OF THE READINGS WERE IN THE 236 OHM - 326 OHM RANGE. THIS INDICATES THAT THE PAD CARTRIDGE WAS ATTACHED TO THE AED CORRECTLY, THE AED WAS CORRECTLY ASSESSING INCOMING DATA, BUT THAT THE PADS WERE NOT MAKING PROPER CONNECTION TO THE PATIENT. THIS CAN BE DUE TO SEVERAL FACTORS SUCH AS IMPROPER PAD PLACEMENT / ADHERENCE, DEBRIS ON THE PADS, CLOTHING INTERFERENCE, BODY SURFACE CONDITIONS SUCH AS WET SKIN OR BODY HAIR. THE DEVICE PLAYED THE EXPECTED AUDIO INSTRUCTIONS ALL CORRECTLY AND NO ERRORS WERE IDENTIFIED ON THE DEVICE AROUND THE TIME OF THE INCIDENT. THE DEVICE WAS RETURNED AND FURTHER INVESTIGATED AT AVIVE. THE PADS USED IN THE EMERGENCY WERE NOT RETURNED AND COULD NOT BE CONSIDERED IN THE INVESTIGATION. TESTING WAS PERFORMED AND CONFIRMED THAT THE DEVICE WAS SUCCESSFULLY ABLE TO DETECT A PATIENT IMPEDANCE ACROSS THE RANGE OF 25-200 OHMS, WAS ABLE TO CORRECTLY CLASSIFY SHOCKABLE OR NOT SHOCKABLE, AND ABLE TO DELIVER A SHOCK AT THE CORRECT ENERGY LEVEL WHEN APPLICABLE. IN ADDITION, THE DEVICE WAS DISASSEMBLED AND INSPECTED. THERE WERE NO DAMAGES OR ASSEMBLY/PCBAS ISSUES IDENTIFIED. THE DEVICE FUNCTION AS EXPECTED AND MET ALL ESSENTIAL PERFORMANCE WITH NO ISSUES IDENTIFIED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT WHEN USING THE AVIVE AED, THE DEVICE AUDIO INDICATED THAT IT WAS UNABLE TO DETECT A PATIENT AND CONTINUED TO PROVIDE THE INSTRUCTIONS TO PLACE THE PADS ON THE PATIENT, DESPITE THE CUSTOMER REPORTING THAT PADS WERE PLACED PROPERLY ON THE PATIENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT WHEN USING THE AVIVE AED, THE DEVICE FAILED TO RECOGNIZE THE PATIENT CONNECTION, AND CONTINUED TO PROVIDE THE INSTRUCTIONS TO PLACE THE PADS ON THE PATIENT, DESPITE THE CUSTOMER REPORTING THAT PADS WERE PLACED PROPERLY ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091418 AVIVE AED WITH AVIVE CONNECT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ AVIVE SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown