BEUDAMED
    FDA Adverse Event Summary report: N

    HAUSTED VIC VIDEOFLUOROSCOPIC IMAGING CHAIR

    MDR report key: 2240746 · Received September 2, 2011

    Report

    Report Number
    2240746
    Date Received
    September 2, 2011
    Date of Event
    July 1, 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

    WHILE SCANNING PATIENT'S ESOPHAGUS USING A VIDEOFLUOROSCOPIC SWALLOW CHAIR, THE FLUOROSCOPY ARM WAS MOVED TOO LOW AND AN ALARM SOUNDED. MOVEMENT FUNCTIONS OF THE FLUORO ARM THEN STOPPED AND DID NOT ALLOW THE ARM TO BE RAISED, TRAPPING THE PATIENT'S LEGS. UPON INVESTIGATION, THERE IS A BUTTON ON THE MAIN CONSOLE AND ON REMOTE CONTROL THAT WILL RESTORE LIFTING CAPABILITY TO THE FLUOROSCOPY ARM, BUT THE STAFF DID NOT RECALL THAT DURING THE EVENT.THERE ARE "HALL EFFECT" SWITCHES IN THE COWLING THAT WERE REPLACED IN 2008 AND KNOWN TO BE FUNCTIONAL AT THE TIME OF THE OCCURRENCE. THESE SENSE AN OBSTRUCTION AND STOP FURTHER MOVEMENT. THESE WERE OPERATIONAL, AS WAS THE MECHANISM TO RESTORE THE LIFTING FUNCTION. IT APPEARS PATIENT'S LOW BMI MAY HAVE CONTRIBUTED TO EVENTS SINCE CHAIR IS LIMITED IN HEIGHT, AND PATIENT WAS LOW IN THE CHAIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR