BEUDAMED
    FDA Adverse Event Death Summary report: N

    VCT 64 SLICE

    MDR report key: 1394350 · Received May 26, 2009

    Report

    Report Number
    2126677-2009-00038
    Event Type
    Death
    Date Received
    May 26, 2009
    Date of Event
    April 28, 2009
    Report Date
    April 30, 2009
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K040372
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE ENGINEERING CONDUCTED A LOG REVIEW, VISUAL INSPECTION, AND PERFORMANCE TESTS ON THE SYSTEM. IT WAS FOUND THAT THE SYSTEM'S TABLE INTERMEDIATE SUPPORT (IMS) POSITION WAS OUT OF TOLERANCE. AS A RESULT, THE SYSTEM COULD NOT GUARANTEE POSITIONING ACCURACY. THE SYSTEM IS DESIGNED SUCH THAT SCANS COULD NOT BE INITIATED IF THE TABLE COULD NOT RECOGNIZE ITS LOCATION. FURTHER EVALUATION REVEALED THAT THE IMS OUT-OF-TOLERANCE ISSUE WAS DUE TO FORCING THE TABLE DRIVE BEYOND ITS RECOGNIZED STOP LOCATION, MOST LIKELY RESULTING FROM USER INTERACTION WHERE EXAGGERATED MOTION OR FORCE WAS APPLIED TO THE TABLE DURING PRIOR EXAMS. GE'S CLINICAL APPLICATION SPECIALIST CONDUCTED ADDITIONAL REVIEW OF THE EVENT. IT WAS CONFIRMED THAT THE PATIENT DID NOT SUSTAIN INJURY FROM THE CT SYSTEM. THE PATIENT HAD INTERNAL HEAD BLEEDING PRIOR TO THE USE OF THE SYSTEM. WHILE THE SYSTEM COULD NOT INITIATE THE SCAN, ITS USE COULD NOT GUARANTEE OR DIRECTLY AFFECT THE PATIENT'S CONDITION. THEREFORE, IT WAS CONCLUDED THAT THE PATIENT'S DEATH WAS NOT CAUSED BY THE CT SYSTEM BUT RATHER BY A PRE-EXISTING CONDITION.

    Description of Event or Problem · 1

    A TRAUMA PATIENT WAS ADMITTED AT THE SITE FOR INTERNAL HEAD BLEEDING AND WAS SCHEDULED FOR A CT SCAN. IT WAS REPORTED THAT THE SITE WAS UNABLE TO ACQUIRE IMAGES DURING THE SCAN ATTEMPT. THE PATIENT EVENTUALLY EXPIRED BEFORE HE WAS SENT TO ANOTHER LAB FOR THE SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VCT 64 SLICE JAK GE MEDICAL SYSTEMS, LLC 5124069

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death