BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA HORIZON CX

    MDR report key: 4142837 · Received September 23, 2014

    Report

    Report Number
    2183553-2014-00021
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    July 25, 2014
    Report Date
    August 22, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K962061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED A BLISTER ABOUT 2X2CM ON HIS LEFT ELBOW, AND A BLISTER ABOUT 4X5CM ON THE RIGHT ELBOW AFTER AN MRI SCAN OF HIS LEFT SHOULDER. THE PATIENT WAS POSITIONED HEAD FIRST, OFFSET SLIGHTLY TO THE RIGHT AND WITH HIS ARMS AT HIS SIDES. THE CUSTOMER CONFIRMED THAT DURING THE EXAM BOTH ELBOWS WERE TOUCHING THE BORE, AND THAT THE GE HEALTHCARE RECOMMENDED PADS WERE NOT USED. HIS RIGHT ELBOW DEVELOPED AN OPEN WOUND AND HE WAS PRESCRIBED SILVADENE CREAM TO PREVENT INFECTION, HE ALSO WAS SEEN AT THE WOUND CARE CENTER AND HAD DEBRIDEMENT DONE ON THE RIGHT ELBOW AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591058 SIGNA HORIZON CX NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC MSF026

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other