BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE LIGHTSPEED 16 SLICE

    MDR report key: 1340015 · Received March 5, 2009

    Report

    Report Number
    1340015
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    February 16, 2009
    Report Date
    March 4, 2009
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US

    Narratives

    Description of Event or Problem · 1

    AS CT TECH WAS ATTEMPTING TO INITIATE SCAN, THE TECH COULD NOT GET THE CT TABLE TO MOVE. THE PATIENT WAS REMOVED FROM THE TABLE AND CT RESTARTED. THE TABLE WAS STILL NOT WORKING AFTER RESTART. A FULL SHUT DOWN WAS PERFORMED AND SYSTEM WAS RESTARTED, BUT TABLE WOULD STILL NOT WORK. GE SERVICE WAS NOTIFIED AND INSTRUCTED STAFF THROUGH VARIOUS TROUBLESHOOTING PROCEDURES WITH NO PROGRESS. MANUFACTURER CAME TO FACILITY THE FOLLOWING DAY. THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER FACILITY FOR THE CT SCAN. A WORK ORDER COULD NOT BE OBTAINED FROM GE AS THIS MANUFACTURER DOES NOT ROUTINELY PROVIDE HARD COPIES ON REPAIRS DONE UNDER THE SERVICE AGREEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE LIGHTSPEED 16 SLICE CT SCANNER JAK GE MEDICAL SYSTEMS, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR NO OTHER THERAPIES| NO OTHER THERAPIES