BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHIMADZU HS-10A

    MDR report key: 19549 · Received September 30, 1994

    Report

    Report Number
    38771-1994-09001
    Event Type
    Malfunction
    Date Received
    September 30, 1994
    Date of Event
    September 2, 1994
    Report Date
    September 9, 1994
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Product Code
    IXK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL ADVISED DISTRIBUTOR ON 9/2/94 THAT THE TABLE HAD TILTED TO 90 DEGREES BY ITSELF. ANESTHESIOLOGIST WAS INJURED TRYING TO KEEP PT FROM FALLING WHEN TABLE TILTED. TECHNICIAN INVOLVED IN THE INCIDENT REPORTED TO COPORATION'S SENIOR IMAGING SPECIALIST THAT THE TABLE WOULD NOT MOVE LATERALLY USING THE FOOTSWITCH. DURING REMOVAL OF THE PT FROM THE TABLE, IT BEGAN TILTING AND WOULD NOT RESPOND TO THE FOOTSWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHIMADZU HS-10A UROLOGICAL X-RAY SYSTEM IXK SHIMADZU MEDICAL SYSTEMS HS-10A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other