BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH

    MDR report key: 23434936 · Received October 31, 2025

    Report

    Report Number
    23434936
    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

    THE PATIENT SENSORS WERE NOT DETECTED IN THE FIELD CREATED BY THE WINDOW FIELD GENERATOR. ASK REP FOR ASSISTANCE AND WAS INSTRUCTED TO MOVE SENSORS TO DIFFERENT LOCATION. REPORTER STATES THE MANUAL DOES NOT STATE TO MOVE THE CABLES. MANUFACTURER RESPONSE FOR MONARCH PATIENT SENSORS, JOHNSON AND JOHNSON (PER SITE REPORTER). ASK REP FOR ASSISTANCE AND WAS INSTRUCTED TO MOVE SENSORS TO DIFFERENT LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299573 MONARCH SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK AURIS HEALTH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female