BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH PLATFORM

    MDR report key: 21118483 · Received January 9, 2025

    Report

    Report Number
    3014447948-2025-00001
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    December 5, 2024
    Report Date
    December 11, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    UDI-DI
    B634MBR000211A1
    PMA / PMN Number
    K231473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN ENCOUNTERED SYSTEM FAULT MESSAGES AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365621 MONARCH PLATFORM BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES QNW AURIS HEALTH, INC. MBR-000211-A B634MBR000211A1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other