BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL ELECTRIC MEDICAL SYSTEMS

    MDR report key: 12280 · Received January 29, 1994

    Report

    Report Number
    12280
    Event Type
    Malfunction
    Date Received
    January 29, 1994
    Date of Event
    August 1, 1993
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 8/2, AFTER A PT EXAM WAS COMPLETED, A TECHNOLOGIST WAS OPERATING THE CT AND A COLLISION OCCURRED BETWEEN THE FOOT EXTENSION ON THE CRADLE AND THE GANTRY WHEN THE TECHNOLOGIST TRIED TO LOWER THE CRADLE WHILE THE GANTRY WAS TILTED AT 22 DEGREES. THE SHEAR FORCE OF THE COLLISION SHEARED OFF THE 3/8" STEEL DOWEL PINS WHICH HELD THE FOOT EXTENSION IN PLACE AND SUBSTANTIALLY DAMAGED THE CRADLE ITSELF. HOSP WAS TOLD TO AVOID SUCH A COLLISION, THE TECHNOLOGIST SHOULD SIMPLY RETURN THE GANTRY TO ZERO DEGREES BEFORE LOWERING THE CRADLE. THIS RESPONSE WAS UNACCEPTABLE. A SPECIAL REWRITE SOFTWARE PROGRAM IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERAL ELECTRIC MEDICAL SYSTEMS GE HIGH SPEED ADVANTAGE CT JAK GE MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other