BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI GXL

    MDR report key: 1994223 · Received February 14, 2011

    Report

    Report Number
    1994223
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE (CLEVELAND)
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    PATIENT TO OUTPATIENT IMAGING FOR PET/CT SCAN UTILIZING NUCLEAR MED GEMINI GXL 16 SLICE MACHINE. PATIENT WAS INJECTED WITH 14.89 MCI OF FDG (FLUORODEOXYGLUCOSE). WHEN ATTEMPTED TO PROCEED WITH SCAN THE SYSTEM "HUNG UP" DUE TO SOFTWARE APPLICATION AND THE BED PORTION OF THE SCANNER WOULD NOT MOVE. PROCEDURE CANCELLED, PATIENT RESCHEDULED. PHILIPS WAS CALLED AND WAS ABLE TO CONNECT REMOTELY AND "RE-INITIALIZED VME RACK, COMPLETED FUNCTION TESTING" AND WAS ABLE TO COMPLETE TESTS FOR REST OF THE DAY. SAME PATIENT RETURNED 1 WEEK LATER TO COMPLETE ORIGINAL TEST AND THE SAME EXACT ISSUE HAPPENED. PATIENT HAD ALREADY BEEN INJECTED WITH 16 MCI OF FLUORINE 18 FDG AND AGAIN THE SCANNER WOULD NOT PROCEED WITH COLLECTING IMAGES. CLINICAL ENGINEERING TROUBLESHOOTING ISSUES, HAVE REQUESTED STAFF TO RUN QC CHECK AND EMULATION PRIOR TO INJECTING PATIENT TO ASCERTAIN MACHINE WILL PERFORM AS EXPECTED. PHILIPS HAS TECHNICIAN ON-SITE THIS WEEK TO TROUBLE SHOOT ISSUES SHOULD ANY ARISE. UNKNOWN AT THIS TIME IF PATIENT WILL BE RESCHEDULED AGAIN OR WHETHER DIAGNOSTIC TEST WILL BE PERFORMED AT ANOTHER FACILITY.MANUFACTURER RESPONSE, ACCORDING TO REPORTER, FOR GEMINI GXL 16, GEMINI GXL: STAFF CALLED PHILIPS WHO WERE ABLE TO TROUBLESHOOT ISSUE AND "UNFREEZE" SCANNER. CONTINUE TO WORK THROUGH ISSUES AS THEY ARISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI GXL GEMINI GXL 16 KPS PHILIPS HEALTHCARE (CLEVELAND) GEMINI GXL 16 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR