BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO

    MDR report key: 18985050 · Received March 27, 2024

    Report

    Report Number
    3004455125-2024-00014
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    February 23, 2024
    Report Date
    March 27, 2024
    Manufacturer
    BARCO NV
    Product Code
    KQM
    UDI-DI
    05415334043312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE UPDATED FIELDS AND FINAL INVESTIGATION RESULTS. THE CUSTOMER HAS PROVIDED ADDITIONAL INFORMATION FROM THEIR INVESTIGATION. THE DETACHMENT OF THE DISPLAY COVER WAS CAUSED BY INCORRECT USE OF THE ARM ON WHICH THE DISPLAY WAS MOUNTED. THE HANDLES PROVIDED FOR MOVING THE DISPLAY ON THE SPRING ARM WERE NOT USED. INSTEAD, THE MONITOR WAS GRIPPED AND MOVED BY THE RECES OR CABLE ENTRY. THE USERS WERE ADVISED BY THE CUSTOMER NOT TO DO THIS IN THE FUTURE. ADDITIONALLY, CABLE COVERS WERE SECURED WITH CABLE TIES. ADDITIONALLY THE CUSTOMER CONFIRMED THAT THE EVENT OCCURRED BEFORE SURGERY AND NOT DURING SURGERY. THERE WAS NO ADDITIONAL ANESTHESIA AND NO PROLONGATION OF THE PROCEDURE. THE PATIENT WAS NOT HARMED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE UPDATED FIELDS AND FINAL INVESTIGATION RESULTS. THE CUSTOMER HAS PROVIDED ADDITIONAL INFORMATION FROM THEIR INVESTIGATION. THE DETACHMENT OF THE DISPLAY COVER WAS CAUSED BY INCORRECT USE OF THE ARM ON WHICH THE DISPLAY WAS MOUNTED. THE HANDLES PROVIDED FOR MOVING THE DISPLAY ON THE SPRING ARM WERE NOT USED. INSTEAD, THE MONITOR WAS GRIPPED AND MOVED BY THE RECES OR CABLE ENTRY. THE USERS WERE ADVISED BY THE CUSTOMER NOT TO DO THIS IN THE FUTURE. ADDITIONALLY, CABLE COVERS WERE SECURED WITH CABLE TIES. ADDITIONALLY THE CUSTOMER CONFIRMED THAT THE EVENT OCCURRED BEFORE SURGERY AND NOT DURING SURGERY. THERE WAS NO ADDIONAL ANESTHESIA AND NO PROLONGATION OF THE PROCEDURE. THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 0

    COVER FOR CABLE CONNECTIONS (PLASTIC COVER) FELL WHEN MOVING THE MONITOR ON THE OPERATING TABLE DURING SURGICAL PREPARATION. OPERATING TABLE UNSTERILE LONGER OPERATION AND ANESTHESIA TIME FOR THE PATIENT. COVER PROBABLY CAME LOOSE DURING CLEANING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527123 BARCO SURGICAL DISPLAY KQM BARCO NV MDSC-8527 05415334043312

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown