BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILT TABLE

    MDR report key: 1399132 · Received June 2, 2009

    Report

    Report Number
    MW5011293
    Event Type
    Malfunction
    Date Received
    June 2, 2009
    Date of Event
    April 9, 2009
    Report Date
    June 2, 2009
    Manufacturer
    AMERICAN ECHO, INC, NOW MEDICAL POSITIONING
    Product Code
    JFB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT SITTING ON THE SIDE OF TILT TABLE. PATIENT USING HANDS TO BRACE SELF IN SITTING POSITION. TILT TABLE FOOT REST FELL ONTO PATIENT'S RIGHT WRIST. FOUND NO DEFECT IN THE TABLE, NOTHING BROKEN OR OUT OF PLACE. THE FOOTBOARD IS SIMPLY FREE TO FOLD UP WHEN THE TABLE IS IN THE PRONE POSITION. CONTACTED MANUFACTURER TO INQUIRE IF THERE WAS A RETROFIT OR SOME WAY TO PREVENT THIS FROM OCCURRING AGAIN. TOLD THE ONLY THING THAT COULD BE DONE TO STOP THE DROP OF THE FOOT BOARD WAS TO TIGHT THE ALLEN SCREWS WHERE THE FOOT BOARD PIVOTS UNTIL THERE WAS ENOUGH DRAG TO KEEP IT FROM FALLING. THERE WAS NO OTHER LOCKING MECHANISM AVAILABLE FROM THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TILT TABLE JFB AMERICAN ECHO, INC, NOW MEDICAL POSITIONING 96701
    2 TILT TABLE JFB AMERICAN ECHO, INC, NOW MEDICAL POSITIONING 96701

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR