BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE 5000

    MDR report key: 229310 · Received June 21, 1999

    Report

    Report Number
    1418957-1999-00002
    Event Type
    Malfunction
    Date Received
    June 21, 1999
    Date of Event
    June 3, 1999
    Report Date
    June 11, 1999
    Manufacturer
    FISCHER IMAGING CORP
    Product Code
    IXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOOT SUPPORT BOARD WAS INSTALLED AND LATCHED ON THE FOOT END OF THE TABLE. WHEN THE TABLE WAS STOOD UPRIGHT, THE LATCHING MECHANISM ON THE OUTSIDE RELEASED, CAUSING THE FOOT SUPPORT TO FALL AT AN ANGLE RESULTING IN THE PT TO FALL TO THE FLOOR, INJURING HER SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE 5000 RADIOGRAPHIC TABLE IXR FISCHER IMAGING CORP ELITE 5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other