BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO

    MDR report key: 20049912 · Received August 23, 2024

    Report

    Report Number
    3004455125-2024-00017
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 23, 2024
    Manufacturer
    BARCO NV
    Product Code
    KQM
    UDI-DI
    05415334026513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS INVESTIGATED THE COMPLAINT BY ANALYZING THE LOG FILES. WE CONCLUDE THAT THE PROBLEM HAS BEEN CAUSED BY A BAD FIBER CONNECTION CABLE IN THE INSTALLATION. THE PROBLEM WAS NOT CAUSED BY A MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 0

    IMAGE DROPS ON SURGICAL DISPLAY LEADING TO PROLONGATION OF SURGICAL PROCEDURE AND ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364349 BARCO SURGICAL DISPLAY KQM BARCO NV MDSC-8232 M3D 05415334026513

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown