BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 1725305 · Received June 9, 2010

    Report

    Report Number
    2020563-2010-00008
    Event Type
    Injury
    Date Received
    June 9, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 13, 2010
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION NECESSARY. THE TECHNICIAN PULLED THE PATIENT PALLET OUT OF THE BORE WITHOUT USING THE MANUAL DRIVE RELEASE UNDER THE BED. THE TECHNICIAN WAS GIVE MEDICATION BY THE EMERGENCY CLINIC TO RELIEVE THE PAIN IN HER NECK AND SHOULDER AREA.

    Description of Event or Problem · 1

    DURING AN MR SCAN, A PATIENT ACTIVATED THE PATIENT CALL SEVERAL TIMES DURING THE EXAM. THE TECHNICIAN PAUSED THE SCAN FROM THE CONTROL CONSOLE AND ENTERED THE MAGNET ROOM TO SPEAK WITH THE PATIENT. THE PATIENT INDICATED THAT HE COULD NOT COMPLETE THE STUDY AND WANTED OUT OF THE MAGNET. THE TECHNICIAN TRIED TO ABORT THE SCAN FROM THE MAGNET BY PUSHING ABORT, START, AND FREE BUTTONS IN RAPID SUCCESSION, BUT COULD NOT FREE THE PATIENT PALLET. AT THIS POINT, THE PATIENT WAS FLAILING HIS ARMS AND LEGS AND THE TECHNICIAN ACTED TO REMOVE THE PATIENT AS QUICKLY AS POSSIBLE. SHE PULLED ON THE PALLET HANDLE, PULLING THE PALLET OUT OF THE BORE WITHOUT ACTIVATING THE MANUAL DRIVE RELEASE. THE TECHNICIAN IMMEDIATELY FELT PAIN IN HER NECK AND SHOULDER AREA. AFTER FINISHING WITH THE PATIENT, AND THREE ADDITIONAL PATIENTS ON THE SCHEDULE, SHE WALKED OVER TO THE EMERGENCY CLINIC ATTACHED TO THE FACILITY FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA MAGNETIC RESONANCE IMAGING SYSTEM LNH TOSHIBA MEDICAL SYSTEMS CORPORATION MRT-1503/P3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R