BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNETOM ESSENZA

    MDR report key: 3964142 · Received July 11, 2014

    Report

    Report Number
    2240869-2014-00942
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 31, 2014
    Manufacturer
    SIEMENS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K071925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS EVALUATED THE SYS REPORTS AND PT IMAGES. ADDITIONALLY, THE SYS WAS EVALUATED AND NO MALFUNCTIONS WERE FOUND AND THE SYS IS OPERATING ACCORDING TO SPECIFICATIONS. IT WAS CONCLUDED THAT THE PT INJURY WAS CAUSED BY A CONDUCTING RF LOOP AS THE PT WAS WEARING GARMENTS THAT CONTAINED METALLIC THREADS. THE MAGNETOM ESSENZA USER MANUAL CLEARLY ADVISES OPERATORS TO ENSURE PTS ARE FREE FROM ALL ITEMS THAT CONTAIN FERROUS METALS. THIS INCIDENT OCCURRED IN (B)(6). THIS REPORTED IS BEING FILED WITH THE FDA ON (B)(4) 2014.

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED BY A USER FACILITY OF A FEMALE PT WHO EXPERIENCED A BURNING SENSATION DURING A SPINE STUDY. THE OPERATOR EXAMINED THE PT AND NOTED A RASH AND BURN MARKS TO THE PT'S BACK AND POSTERIOR. THE PT WAS TREATED WITH ANTIBIOTIC CREAM. THE PT EXAMINATION LASTED FOR FIFTEEN MINUTES AND IT WAS NOTED THE PT WAS WEARING THEIR OWN CLOTHING WHICH INCLUDED METALLIC THREADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408061 MAGNETOM ESSENZA SYS, NUC. MAG. RESONANCE IMAGING LNH SIEMENS HEALTHCARE 10836666

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other