BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH WINDOW FIELD GENERATOR

    MDR report key: 23434909 · Received October 31, 2025

    Report

    Report Number
    23434909
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 10, 2025
    Manufacturer
    AURIS HEALTH, INC
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT FLOW SENSORS AND WINDOW FIELD GENERATOR WERE NOT CONNECTING AND SENSORS WERE NOT DETECTED. MANUFACTURER RESPONSE FOR MONARCH WINDOR FIELD GENERATOR, (BRAND NOT PROVIDED) (PER SITE REPORTER). THEY ASKED THE TEAM TO MOVE THE SENSORS AND THINK THAT THE BED IS INTERFERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894815 MONARCH WINDOW FIELD GENERATOR SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK AURIS HEALTH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male