BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOGRAPHIC/FLUOROSCOPIC X-RAY UNIT-TABLE

    MDR report key: 35154 · Received August 9, 1996

    Report

    Report Number
    MW1009681
    Event Type
    Malfunction
    Date Received
    August 9, 1996
    Date of Event
    April 24, 1996
    Report Date
    April 29, 1996
    Manufacturer
    GENERAL ELECTRIC CO.
    Product Code
    KXJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A VENOGRAM PROCEDURE WITH THE X-RAY TABLE IN A SEMI-UPRIGHT POSITION (ESTIMATED 45 DEGREES) THE FLOATING TABLE TOP SEEMED TO BREAK LOOSE FROM THE REST OF THE TABLE ASSEMBLY AND SLIDE TOWARDS THE FLOOR. X-RAY PERSONNEL WERE ABLE TO MANUALLY CONTROL THE MOVEMENT OF THE TABLE TOP. THE TABLE WAS PLACED IN A HORIZONTAL POSITION AND THE PT SAFELY REMOVED WITHOUT INJURY. UPON INSPECTION BY EQUIPMENT SVC PERSONNEL IT WAS DETERMINED THAT A GEAR THAT HOLDS THE TABLE TOP CHAIN SLID OFF THE SHAFT OF THE MOTOR. THUS ALLOWING THE TABLE TOP TO FLOAT FREELY. THIS EQUIPMENT IS NORMALLY MAINTAINED BY A THIRD PARTY RADIOLOGY SVC VENDOR. THE THIRD PARTY VENDOR REPLACED THE GEAR BOX IN QUESTION AROUND 8/3/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOGRAPHIC/FLUOROSCOPIC X-RAY UNIT-TABLE RADIOGRAPHIC/FLUOROSCOPIC X-RAY UNIT-TABLE KXJ GENERAL ELECTRIC CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other