BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATOM EMOTION 6 (2007)

    MDR report key: 3032549 · Received April 3, 2013

    Report

    Report Number
    2240869-2013-02788
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SIEMENS AG
    Product Code
    JAK
    PMA / PMN Number
    K023687
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAN REPLACEMENT AND SERVICE TO THE SYSTEM WAS SUCCESSFUL AND THE CT EMOTION 6 IS FULLY OPERATIONAL. THE RESULTING ELECTRICAL SHOCK TO THE ENGINEER WAS NOT CAUSED BY A SYSTEM MALFUNCTION AS THE SYSTEM WAS OPERATING AS INTENDED. BECAUSE THIS EVENT INVOLVED A SIEMENS CSE, IT WILL BE ADDRESSED INTERNALLY THROUGH OUR ENVIRONMENTAL HEALTH AND SAFETY-(EHS) GROUP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A SIEMENS CUSTOMER SERVICE ENGINEER RECEIVED AN ELECTRICAL SHOCK OF 400 VDC NOMINAL WHEN HIS HAND GENTLY BRUSHED THE EXPOSED SLIP RING OF AN EMOTION 6 CT AIR COOLED GANTRY WHILE PERFORMING SERVICE. REPORTEDLY ON (B)(6) 2013, THE CUSTOMER CALLED SIEMENS REGARDING A STRANGE NOISE IN THE GANTRY AND REQUESTED SERVICE. ON (B)(6) 2013, TWO SIEMENS CUSTOMER SERVICE ENGINEERS (CSES) DE-ENERGIZED THE SYSTEM AND REMOVED THE GANTRY COVER TO REPLACE THE FAN INSIDE THE GANTRY OF THE CT SCANNER. IN ORDER TO DETERMINE THE REPLACEMENT WAS SUCCESSFUL AND THERE WAS NO LONGER A STRANGE NOISE FROM THE GANTRY, THE CSES STARTED (ENERGIZED) THE SYSTEM AND ONE ENGINEER WAS POSITIONED IN THE FRONT OF THE GANTRY, WHILE THE OTHER ENGINEER WAS POSITIONED BEHIND THE GANTRY. DURING THIS TROUBLESHOOTING, A HOSPITAL TECHNICIAN CALLED INTO THE ROOM WITH THE CSES, AND THE ENGINEER BEHIND THE SYSTEM TURNED TOWARDS THE TECHNICIAN AND HIS HAND GENTLY BRUSHED THE GANTRY CAUSING THE SHOCK. THE CSE SOUGHT IMMEDIATE MEDICAL ATTENTION AND WAS RELEASED FROM CARE LATER THAT EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135587 SOMATOM EMOTION 6 (2007) SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS AG 10165888

    Patients

    Seq Age Sex Outcome Treatment
    1 Other