BEUDAMED
    FDA Adverse Event Summary report: N

    GREEN SERIES 777

    MDR report key: 3809767 · Received May 2, 2014

    Report

    Report Number
    3809767
    Date Received
    May 2, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    DXQ
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    EQUIPMENT PANEL HANGING ABOVE THE PATIENT'S BED FELL OFF BRACKET AND STRUCK THE PATIENT IN THE FOREHEAD. THE PANEL IS FASTENED TO THE WALL USING AN L-SHAPED BRACKET PROVIDED BY THE MANUFACTURER. THE BED WAS NOT AGAINST THE WALL AND THE WALL WAS NOT TOUCHED BY STAFF OR OTHER. THE BED WAS BEING MOVED INTO AN UPRIGHT POSITION BY A NURSE AT THE TIME OF THE INCIDENT. THE PANEL IN QUESTION HOLDS SEVERAL INSTRUMENTS, INCLUDING AN OTOSCOPE, A THERMOMETER, AND BLOOD PRESSURE CUFF. THE PATIENT WAS TAKEN FOR A CT SCAN, WITH NEGATIVE RESULTS OTHER THAN MINOR SOFT-TISSUE DAMAGE. THE BIOMED STAFF HAS CONCERNS WITH THE WAY THE PANEL IS DESIGNED IN THE BACK IN THAT IT COULD BE INADVERTENTLY KNOCKED OFF THE WALL AS IT IS ONLY HELD BY GRAVITY. OUR 'WORK AROUND' HAS BEEN TO SCREW IN THE CENTER OF THE BOTTOM OF THE PANEL TO THE WALL, SO IT CANNOT BE LIFTED UP. WE HAVE MADE THE MANUFACTURER AWARE OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265506 GREEN SERIES 777 INTEGRATED WALL PANEL FOR ANEROID MANOMETER, OTOSCOPE, THERM DXQ WELCH ALLYN, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR