BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T HDX

    MDR report key: 3934843 · Received June 20, 2014

    Report

    Report Number
    2183553-2014-00014
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 20, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS UPGRADED FROM EXCITE TO HDX. THE DEVICE MANUFACTURE DATE PROVIDED IS FOR THE EXCITE SYSTEM. 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 UNDERGOING AN MRI OF THEIR LUMBAR SPINE SUSTAINED BURNS TO HIS RIGHT THUMB AND RIGHT THIGH/BUTTOCK. THE PATIENT WAS POSITIONED HEAD FIRST SUPINE WITH HIS ARMS AT HIS SIDES. THE PATIENT WAS PADDED BY THE ARMS TO PREVENT CONTACT TO THE SIDES OF THE MAGNET BORE AND PADDING BETWEEN THE PATIENT'S LEGS. THE PATIENT WAS COVERED WITH A COTTON SHEET, WITH NO ADDITIONAL PADDING UTILIZED TO ISOLATE SKIN TO SKIN CONTACT AT THE AREAS OF OBSERVED CONTACT BETWEEN THE PATIENT'S ARMS AND HIS BODY. THE PATIENT DID NOT ALERT THE TECHNOLOGIST DURING THE EXAM TO ANY WARMING OR DISCOMFORT, AND THE MRI EXAM WAS COMPLETED IN ITS ENTIRETY. AFTER THA PATIENT WAS RETURNED TO HIS HOSPITAL ROOM, A HOSPITAL NURSE CONTACTED THE MRI DEPARTMENT TO ALERT THEM THAT THE PATIENT HAD OBSERVED BURNS TO HIS RIGHT THUMB AND RIGHT THIGH/BUTTOCK. THE PATIENT WAS EVALUATED TO HAVE SUSTAINED SECOND DEGREE BURNS WITH BLISTERS ON THE RIGHT THUMB AND RIGHT THIGH/BUTTOCK, AND WAS TREATED WITH SILVEROL, A PRESCRIPTION MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364074 1.5T HDX LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other