BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOSHIBA

    MDR report key: 1356389 · Received April 2, 2009

    Report

    Report Number
    2020563-2009-00004
    Event Type
    Other
    Date Received
    April 2, 2009
    Date of Event
    February 16, 2009
    Report Date
    March 5, 2009
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORP.
    Product Code
    LNH
    PMA / PMN Number
    080038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION NECESSARY. THERE WAS NO PROBLEM WITH THE SYSTEM. THE EVENT IN #5 WAS REPORTED TO THE TOSHIBA CUSTOMER ENGINEER (CE) DURING A FOLLOW-UP CALL TO CHECK ON THE SYSTEM. THE TOSHIBA CE WAS ALSO TOLD THAT IT IS BELIEVED THE EXPOSURE TO THE MAGNETIC FIELD CAUSED THE FRAGMENTS TO DISLODGE OR MOVE. THE TECHNICIAN MISSED 2 WEEKS OF WORK AND IS NOW BACK TO WORK. ADDITIONALLY, HE WOULD NO LONGER BE ABLE TO WORK AROUND THE MR SYSTEM.

    Description of Event or Problem · 1

    ONE OF THE CUSTOMER'S BIOMEDICAL TECHNICIANS ASSISTED THE TOSHIBA CUSTOMER ENGINEER DURING IN SERVICING OF THE MRI SYSTEM ON (B) (6) 2009. IT WAS REPORTED THAT SEVERAL DAYS LATER, THE BIOMEDICAL ENGINEER COMPLAINED ABOUT PAIN IN HIS HIP AND SOUGHT MEDICAL ATTENTION. HE WAS TREATED FOR MOVEMENT OR DISLOCATION OF SOME METAL FRAGMENTS IN HIS HIP SUSTAINED FROM A HUNTING ACCIDENT (B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH TOSHIBA MEDICAL SYSTEMS CORP. MRT-1503/P2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other