BEUDAMED
    FDA Adverse Event Other Summary report: N

    HORIZON LX

    MDR report key: 700218 · Received March 27, 2006

    Report

    Report Number
    700218
    Event Type
    Other
    Date Received
    March 27, 2006
    Date of Event
    February 9, 2006
    Report Date
    March 27, 2006
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN MRI STUDY, A PATIENT VERBALIZED THAT SHE WAS EXPERIENCING A WARM SENSATION ON BOTH HER UPPER ARMS. WHEN THE STUDY WAS COMPLETED PATIENT HAD WHAT LOOKED LIKE "SUNBURN" ON BOTH OF HER UPPER ARMS. THE PATIENT WAS EXAMINED BY A PHYSICIAN, COOL COMPRESSES WERE APPLIED AND THE PATIENT REPORTED SOME RELIEF OF HER SYMPTOMS AFTER 45 MINUTES. THE PATIENT WAS DISCHARGED WITH INSTRUCTIONS TO FOLLOW UP WITH HER PHYSICIAN IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON LX MRI, MOBILE LNH GE MEDICAL SYSTEMS, LLC 1.5 T TESLA HORIZON LX SOFTWARE RELEASE 9.0 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR