BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVIVER

    MDR report key: 23851862 · Received December 19, 2025

    Report

    Report Number
    3003521780-2025-02123
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Report Date
    December 19, 2025
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    MKJ
    PMA / PMN Number
    K013896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS AED WAS NOT ABLE TO FUNCTION AND THEREFORE ANALYSIS OF THE DEVICE NOR A REVIEW OF ITS ELECTRONIC LOG FILES WERE POSSIBLE AND THUS THE ROOT CAUSE COULD NOT BE DETERMINED. THE CUSTOMER WAS REFERRED TO A DISTRIBUTOR TO PURCHASE A REPLACEMENT BATTERY AND AS A FOLLOW-UP WITH THE CUSTOMER, THE PROPER MAINTENANCE OF THIS DEVICE WAS REVIEWED.

    Additional Manufacturer Narrative · 0

    THIS AED WAS NOT ABLE TO FUNCTION AND THEREFORE ANALYSIS OF THE DEVICE NOR A REVIEW OF ITS ELECTRONIC LOG FILES WERE POSSIBLE AND THUS THE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE FACT THAT THIS AED IS BEYOND ITS 10-YEAR DESIGN LIFE, AND THE REPORTED PROBLEM, THE CUSTOMER WAS ADVISED TO REMOVE THE AED FROM SERVICE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THEIR AED'S ASI IS FLASHING RED, AND THE AED WILL NOT POWER ON. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259887 REVIVER AUTOMATED EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, L.L.C. DDU-100B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown