BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHAMPAINE

    MDR report key: 597799 · Received March 4, 2004

    Report

    Report Number
    3019090-2004-00001
    Event Type
    Other
    Date Received
    March 4, 2004
    Date of Event
    February 24, 2004
    Report Date
    March 4, 2004
    Manufacturer
    GETINGE USA, INC, F.K.A. MDT DIAGNOSTIC, INC.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS INSTRUCTED TO MOVE FROM BED #1 TO HEAD SECTION OF THE BED #2 WITH ATTACHED MAYFIELD ADAPTER. AS PATIENT APPLIED BODY WEIGHT IN EXCESS OF HEADBOARD WEIGHT CAPACITY THE HEADBOARD FAILED ALLOWING PATIENT TO FALL TO THE FLOOR. THE COMBINATION OF MAYFIELD ADAPTER (ADDED TO HEADBOARD) AND PATIENTS WEIGHT EXCEEDED THE WEIGHT LIMIT FOR THE HEADBOARD. AS A RESULT OF THE FALL PATIENT WAS TAKEN TO X-RAY. X-RAY NEGATIVE FOR BROKEN BONES, PATIENT DID DISPLAY SOFT TISSUE SWELLING OF THE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHAMPAINE SURGICAL TABLE FQO GETINGE USA, INC, F.K.A. MDT DIAGNOSTIC, INC. 1900-RC *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR