BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNETOM SYMPHONY SYNGO MR

    MDR report key: 2853076 · Received August 27, 2012

    Report

    Report Number
    2240869-2012-07083
    Event Type
    Injury
    Date Received
    August 27, 2012
    Date of Event
    July 14, 2012
    Report Date
    July 27, 2012
    Manufacturer
    SIEMENS AG
    Product Code
    LNH
    PMA / PMN Number
    K971684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMAGES WERE SENT TO SIEMENS UPTIME CENTER FOR FURTHER EVALUATION. THE UNIT WILL BE EVALUATED BY A THIRD PARTY VENDOR, (B)(4) 2012. OUR FACTORY EXPERTS SPECULATE THAT THE BURNS WERE CAUSED BY AN RF CURRENT LOOP OR DUE TO ELECTRICALLY CONDUCTIVE MATERIAL ON THE THIGHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE BARIATRIC PATIENT RECEIVED BURNS ON THE INSIDE OF BOTH THIGHS. THE REPORTED BURNS WERE APPROXIMATELY 2X2 CM. THE PATIENT WAS OVER (B)(6) AND THE CUSTOMER HAD TROUBLE TUNING TO THE PATIENT DUE TO COILS TOUCHING THE SCANNER. AFTER THE CUSTOMER WAS ABLE TO TUNE IN TO THE PATIENT, THEY HAD DIFFICULTY OBTAINING GOOD IMAGES DUE TO THE SIZE OF THE PATIENT AND COIL POSITIONING. THE PATIENT WAS IN THE SCANNER FOR ALMOST THREE HOURS. IT WAS STATED THAT DURING THE SCAN THE PATIENT WAS WEARING A HOSPITAL GOWN AND A TOWEL WAS PLACED IN-BETWEEN THE PATIENT'S LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNETOM SYMPHONY SYNGO MR MAGNETIC RESONANCE DIAGNOSTIC DEVIC, PRODUCT CODE: LNH LNH SIEMENS AG 07104594

    Patients

    Seq Age Sex Outcome Treatment
    1 Other