BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGNA MR

    MDR report key: 2011698 · Received March 1, 2011

    Report

    Report Number
    2183553-2011-00009
    Event Type
    Other
    Date Received
    March 1, 2011
    Date of Event
    December 29, 2010
    Report Date
    March 1, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC.
    Product Code
    LNH
    PMA / PMN Number
    K041476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POSSIBLE PT WARMING OR BURN DURING A MR SCAN OF THE BRAIN AND HAND. THE PT WAS POSITIONED HEAD FIRST IN THE SCANNER. THE PT WAS SEDATED DURING THE SCAN, AND WAS PADDED PER THE TECH WHO PERFORMED THE SCANNING. THE PT REPORTEDLY RECEIVED A BLISTER ON THE ELBOW THAT REQUIRED MEDICAL INTERVENTION. DETAILS OF THE INJURY, SUCH AS LOCATION, DEGREE OF INJURY, ETC., ARE UNK AT THIS TIME. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 2

    IT WAS REPORTED THAT THERE WAS A POSSIBLE PT WARMING OR BURN DURING A MR SCAN OF THE BRAIN AND HAND. THE PT WAS POSITIONED HEAD FIRST IN THE SCANNER. THE PT WAS SEDATED DURING THE SCAN, AND WAS PADDED PER THE TECH WHO PERFORMED THE SCANNING. THE PT REPORTEDLY RECEIVED A BLISTER ON THE ELBOW THAT REQUIRED MEDICAL INTERVENTION. DETAILS OF THE INJURY, SUCH AS LOCATION, DEGREE OF INJURY, ETC., ARE UNK AT THIS TIME. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA MR NUCLEAR MAGNETIC RESONANCE IMAGING SYS LNH GE MEDICAL SYSTEMS, LLC. 5110607

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other
    2 60 YR Other