BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T SIGNA HDX ECHOSPEED

    MDR report key: 1993211 · Received January 18, 2011

    Report

    Report Number
    2183553-2011-00003
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    April 12, 2010
    Report Date
    January 18, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED A BURN FOLLOWING A MRI SCAN OF THE BRAIN AND A MRA OF THE HEAD AND NECK. THE PATIENT REPORTEDLY INFORMED THE HOSPITAL OF THE BURN TWO MONTHS AFTER THE MR SCAN, STATING THAT THEY HAD SEEN A WOUND SPECIALIST FOR THE INJURY. THE SIZE OF THE BURN IS UNKNOWN AT THIS TIME. THE PATIENT WAS REPORTEDLY POSITIONED HEAD FIRST, SUPINE, WITH ARMS AT THE SIDE. A TOTAL OF 17 SCANS WERE PERFORMED DURING THE EXAM, WITH A TOTAL EXAM TIME OF APPROXIMATELY 1 HOUR AND 30 MINUTES. THE SITE COULD NOT RECALL IF PADDING WAS USED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5T SIGNA HDX ECHOSPEED MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other