BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO

    MDR report key: 19738619 · Received July 15, 2024

    Report

    Report Number
    3004455125-2024-00016
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 15, 2024
    Manufacturer
    BARCO NV
    Product Code
    KQM
    UDI-DI
    05415334001367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    WE WERE INFORMED ABOUT A HOSPITAL EXPERIENCING 2 ISSUES. WITH BOTH OF OLYMPUS TOWERS GOING DOWN TODAY IT IS AFFECTING SERVICE DELIVERY OF UROLOGY. THE HOSPITAL'S UROCAMS AND URETEROSCOPES ONLY FIT INTO THIS TOWER (AND ON PENDANT IN OR5 IF ORTHOPAEDICS IS NOT OCCUPYING THE ROOM) RECENTLY THE CABLE WAS CHANGED, HOWEVER INTERMITTENTLY IT HAS TURNED OFF MID PROCEDURE. THE STANDBY LIGHT ALTERNATES FROM RED TO GREEN AND NOW THE MONITOR WILL NOT TURN ON AT ALL. THE PATIENT WAS NOT AFFECTED. THERE WAS DIATHERMY USED DURING THE CASE. THE LEADS WERE SEPARATED TO MINIMISE INTERFERENCE. THE UNIT WAS NOT DISCONNECTED FOR 5 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286844 BARCO MDSC-8231 KQM BARCO NV MDSC-8231 12G 05415334001367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown