BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTX

    MDR report key: 1313991 · Received February 16, 2009

    Report

    Report Number
    9611343-2009-00008
    Event Type
    Malfunction
    Date Received
    February 16, 2009
    Date of Event
    January 23, 2009
    Report Date
    February 16, 2009
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZI
    PMA / PMN Number
    K931049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RADIATION TECHNICIAN REPORTED THAT DURING AN EXAM, WHEN MOVING THE TABLETOP IN A FORWARD DIRECTION, THE TABLE LIFTED UP APPROXIMATELY 10 CM FROM THE INITIAL LEVEL ON THE FOOT SIDE. THE OPERATOR HELD THE TABLETOP, AND NO PATIENT INJURY OCCURRED. THE EXAM WAS COMPLETED SUCCESSFULLY ON THE SAME SYSTEM. INITIAL INSPECTION OF THE DEVICE WAS COMPLETED BY THE GE FIELD SERVICE ENGINEER (FE). THE FE NOTED THAT THE SCREWS FIXING THE SAFETY LOCKING PLATES ON THE RAIL WERE MISSING ON BOTH SIDES. THE FE ADDED SCREWS AND TIGHTENED THEM, WHICH CORRECTED SYSTEM OPERATION. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTX VASCULAR X-RAY SYSTEM IZI GE MEDICAL SYSTEMS SCS 46-302109G5

    Patients

    Seq Age Sex Outcome Treatment
    1