BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO

    MDR report key: 18281332 · Received December 7, 2023

    Report

    Report Number
    3004578804-2023-00004
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Report Date
    December 5, 2023
    Manufacturer
    BARCO NV
    Product Code
    DXJ
    PMA / PMN Number
    K173381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE LOG FILES INDICATED THAT THE INSTALLER HAD NOT CORRECTLY CONFIGURED THE INSTALLATION CORRECTLY. INSTRUCTIONS FOR USE AND TRAINING MATERIAL ARE CORRECT.

    Description of Event or Problem · 0

    ALL DISPLAYS SUDDENLY GOING BLACK DURING SURGERY (ENDOSCOPY). HAD TO RESELECT SOURCES FROM TOUCH PANEL, THEN OK. ALL DISPLAYS SUDDENLY GOING BLACK DURING SURGERY (ENDOSCOPY) WHEN SELECTING A SOURCE TO OTHER SINK (EXTERNAL RECORDER). HAD TO RESELECT SOURCES FROM TOUCH PANEL, THEN OK. SUDDENLY BAD IMAGE QUALITY ON SURGERY MONITORS (3D IMAGE) NO HARM TO THE PATIENTS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199865 BARCO NEXXISOR DXJ BARCO NV NEXXISOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown