BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH PLATFORM

    MDR report key: 21032403 · Received December 29, 2024

    Report

    Report Number
    3014447948-2024-00029
    Event Type
    Malfunction
    Date Received
    December 29, 2024
    Date of Event
    December 4, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    UDI-DI
    B634MBR000211A1
    PMA / PMN Number
    K231473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE PATIENT WAS ON THE TABLE UNDER ANESTHESIA PHYSICIAN EXPERIENCED EM SENSOR ERROR. THE PHYSICIAN ELECTED TO ABORT THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718483 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