BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATOM SENSATION 16

    MDR report key: 3955174 · Received July 18, 2014

    Report

    Report Number
    2240869-2014-05324
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 23, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    JAK
    PMA / PMN Number
    K040665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS WAS NOTIFIED OF THE REPORTED EVENT ON (B)(4) 2014. THIS MDR WILL BE MAILED ON (B)(4) 2014. INVESTIGATION SHOWS THAT ALL FUNCTIONS OF THE CT TABLE ARE OPERATING CORRECTLY AND ARE WITHIN SPECIFICATION. THE CT SYSTEM OPERATOR'S MANUAL CAUTIONS THE USER TO ALWAYS FIX AND OBSERVE THE PATIENT DURING SYSTEM MOVEMENTS TO AVOID INJURY. CONSIDERING THIS, NO CORRECTIVE ACTION IS INITIATED.

    Description of Event or Problem · 1

    A THIRD PARTY SERVICE PROVIDER INFORMED SIEMENS ON (B)(6) 2014 THAT A PATIENT FELL OFF OF THE CT SCANNER TABLE. REPORTEDLY, THE CUSTOMER LOADED THE PATIENT ONTO THE TABLE BY USING A BOARD USED FOR HEAD SCANS AND THE PATIENT WAS NOT STRAPPED ONTO THE TABLE. THE SCOUT SCAN WAS COMPLETED AND ACCORDING TO THE TECH THE PATIENT SLIGHTLY RAISED THEIR LEG AND AT THAT POINT THEY SLID DOWNWARD TOWARD THE GANTRY BORE AND MADE CONTACT. THE TECH SAID THE PATIENT COMPLAINED OF BACK PAIN AND WAS TAKEN TO THE EMERGENCY ROOM. THERE IS NO OTHER AVAILABLE INFORMATION ON THE PATIENT'S STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423149 SOMATOM SENSATION 16 SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS MEDICAL SOLUTIONS USA, INC. 07393114 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TABLE