BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH PATIENT SENSOR

    MDR report key: 23434937 · Received October 31, 2025

    Report

    Report Number
    23434937
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    July 31, 2025
    Report Date
    September 9, 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

    DURING THE CASE, THE PATIENT SENSING CABLES DID NOT REGISTER. ATTEMPTED TO SWITCH PORTS. FINALLY HAD TO USE BACK UP SENSING CABLES SO IT WOULD REGISTER AS VALID. NO PATIENT HARM. MANUFACTURER RESPONSE FOR MONARCH PATIENT SENSOR, JOHNSON AND JOHNSON (PER SITE REPORTER). REP WAS PRESENT WHEN THIS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299574 MONARCH PATIENT SENSOR SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK AURIS HEALTH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female