BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH

    MDR report key: 19877067 · Received July 30, 2024

    Report

    Report Number
    MW5157856
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    July 22, 2024
    Report Date
    July 26, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERGOING SCHEDULED NAVIGATIONAL ROBOTIC BRONCHOSCOPY. MONARCH WOULD NOT PROPERLY STOW ARMS, ACKNOWLEDGE PATIENT OR INITIALIZE. REP NOTIFIED AND TROUBLESHOOTING ATTEMPTED BY CLINICAL STAFF WITHOUT RESOLUTION. PROVIDER AWARE, CLINICAL DECISION TO PERFORM PROCEDURE WITHOUT NAVIGATIONAL ROBOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885922 MONARCH BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ AURIS HEALTH, INC. MONARCH PLATFORM 100-240V, 50/60

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female