BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH PATIENT FLOW SENSOR

    MDR report key: 23434966 · Received October 31, 2025

    Report

    Report Number
    23434966
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    August 21, 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 SENSORS AND WINDOW FIELD GENERATOR NOT COMMUNICATING. MANUFACTURER RESPONSE FOR MONARCH PATIENT FLOW SENSOR, JOHNSON AND JOHNSON (PER SITE REPORTER). REP SUGGESTS ALTERNATE PLACEMENT AND STATES IT MAY BE THE BED INTERFERRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085581 MONARCH PATIENT FLOW SENSOR SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK AURIS HEALTH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male