BEUDAMED
    FDA Adverse Event Summary report: N

    HAUSTED VIC VIDEOFLUOROSCOPIC CHAIR

    MDR report key: 2240747 · Received September 2, 2011

    Report

    Report Number
    2240747
    Date Received
    September 2, 2011
    Date of Event
    July 13, 2011
    Report Date
    September 2, 2011
    Manufacturer
    HAUSTED PATIENT HANDLING SYSTEMS, LLC
    Product Code
    FZK
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PERFORMING VIDEO SWALLOW ON SMALL ADULT, THE FLUOROSCOPY ARM MOVED TOO LOW AND THE OBSTRUCTION ALARM SOUNDED, AND CONTROL TO MOVE THE FLUOROSCOPY STOPPED (SAFETY SWITCH). HOWEVER, PATIENT'S LEGS WERE TRAPPED UNDER THE EQUIPMENT. CHAIR COULD NOT BE LOWERED TO FREE PATIENT.IN REVIEW, THERE WAS A SAFETY SWITCH ON THE MAIN CONSOLE AND ON THE REMOTE TO ALLOW THE FLUORO ARM TO BE MOVED UP, BUT STAFF WERE NOT AWARE AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAUSTED VIC VIDEOFLUOROSCOPIC CHAIR CHAIR, IMAGING, VIDEOFLUOROSCOPIC FZK HAUSTED PATIENT HANDLING SYSTEMS, LLC * *
    2 MULTIDIAGNOST 4 X-RAY SYSTEM, RAD/FLUORO JAA PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. MULTIDIAGNOST 4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR