BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVIVER

    MDR report key: 22060700 · Received May 21, 2025

    Report

    Report Number
    3003521780-2025-00428
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Report Date
    April 22, 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

    Narratives

    Additional Manufacturer Narrative · 0

    THIS AED NOR ITS ELECTRONIC LOG FILES WERE RETURNED AND THUS THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THEIR AED'S ASI IS FLASHING RED, AND THEIR AED'S AUDIO PROMPTS ARE NOT CLEARLY AUDIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57684 REVIVER AUTOMATED EXTERNAL DEFIBRILLATORS MKJ DEFIBTECH, L.L.C. DDU-100B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown