BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNA HDX3T

    MDR report key: 992177 · Received February 6, 2008

    Report

    Report Number
    2183553-2008-00004
    Event Type
    Malfunction
    Date Received
    February 6, 2008
    Report Date
    October 8, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE INVESTIGATION IS ON-GOING. GE IS ATTEMPTING TO OBTAIN THE DATE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SLICE POSITION BETWEEN ZOOM MODE AND WHOLE MODE CHANGES BY APPROXIMATELY 15MM DURING A PHANTOM SCAN, RESULTING IN A DISCREPANCY OF SLICE LOCATION BETWEEN THE TWO MODES. THERE WAS NO PATIENT INVOLVEMENT, AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA HDX3T LNH GE MEDICAL SYSTEMS, LLC 2337610 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA