BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGNA EXCITE

    MDR report key: 851361 · Received May 8, 2007

    Report

    Report Number
    2183553-2007-00012
    Event Type
    Other
    Date Received
    May 8, 2007
    Date of Event
    April 10, 2007
    Report Date
    May 8, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS A POSSIBILITY THAT THIS ISSUE COULD LEAD TO MISDIAGNOSIS. HOWEVER, GOOD CLINICAL PRACTICE WOULD DICTATE THAT DIAGNOSTIC AND TREATMENT DECISIONS WOULD BE BASED ON PT OVERALL EXAM, CLINICAL SYMPTOMS AND LAB DATA ETC., AND NOT ON A SINGLE MRI SERIES. THE MR SYSTEM WAS OPERATING AS INTENDED AND THERE IS NO EVIDENCE THAT THE SYS MALFUNCTIONED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMAGE, RESULTING FROM AN MRI SCAN, WAS UNEVEN WHEN USING 8-CHANNEL HEAD AND NECK COIL AND USING THE DIFFUSION AND ASSET PROTOCOLS. THE CONCERN IS THAT THERE MAYBE A POSSIBILITY OF MISDIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA EXCITE MR LNH GE MEDICAL SYSTEMS, LLC 2142600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR