BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASCAN TABLE

    MDR report key: 1958805 · Received January 3, 2011

    Report

    Report Number
    1958805
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 3, 2011
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DUE TO THE DESIGN, WHEN PATIENTS ARE GETTING DOWN FROM THE GURNEY, THEY ARE SOMETIMES GETTING THEIR PANT LEGS CAUGHT UP ON THE METAL PIECE THAT STICKS UP FROM THE CASTERS, CAUSING THEM TO FALL. IT IS REALIZED THAT THIS IS AN OLDER MODEL, AND THAT THE NEWER MODELS HAVE A DIFFERENT DESIGN, BUT IT IS FELT THAT THERE SHOULD BE SOME SORT OF MANUFACTURER "FIX" TO THESE PRODUCTS THAT ARE STILL IN USE. WE WOULD RECOMMEND A RECALL OF THE OLDER MODELS.====================== HEALTH PROFESSIONAL'S IMPRESSION======================POOR DESIGN. A 2-3 INCH METAL BAR STICKS UP FROM THE BOTTOM CASTER WHEELS. WHEN PATIENTS EXIT THE GURNEY (EVEN THOUGH THEY ARE SUPPOSED TO EXIT FROM THE MIDDLE OF THE GURNEY) THEY GET CAUGHT ON THIS PART OF THE GURNEY.====================== MANUFACTURER RESPONSE FOR ULTRASCAN TABLE, ULTRASCAN TABLE======================THEY HAD RESERCHED IT IN THE PAST BUT WERE UNABLE TO REPRODUCE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASCAN TABLE ULTRASCAN TABLE LGX MEDICAL POSITIONING, INC. 8089 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR