BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 3051444 · Received April 10, 2013

    Report

    Report Number
    2020563-2013-00002
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    December 18, 2012
    Report Date
    March 11, 2013
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    MQB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FIRST REPORTED TO THE TOSHIBA CUSTOMER ENGINEER (CE) ON (B)(6) 2013 THAT TWO PATIENTS ALLEGEDLY RECEIVED RADIATION BURNS DURING THEIR EXAMS AND THAT THE PATIENT ENTRANCE DOSE LEVEL ON THE LATERAL TUBE EXCEEDED 10MR/MIN. BOTH EXAMS WERE CONDUCTED BY THE SAME PHYSICIAN. THE HOSPITAL REPORTED THAT THE EXAM CONDUCTED ON (B)(6) 2012 WAS OVER 5 HOURS IN LENGTH AND THE MAJORITY OF RADIATION WAS FROM FLUORO. SHE ADDITIONALLY REPORTED THAT THERE WAS APPROXIMATELY 268 MINUTES OF FLUORO TIME. THE TOTAL DOSE RECEIVED BY THE PATIENT WAS: FRONTAL - 128,441 CGYCM2, LATERAL - 260,549 CGYCM2. ON (B)(6) 2013, IT WAS REPORTED THAT THE CUSTOMER'S PHYSICIST CHECKED THE PATIENT ENTRANCE DOSE LEVELS ON THE FRONTAL AND LATERAL TUBES. THE FRONTAL WAS LESS THAN 10MR/MIN AND THE LATERAL EXCEEDED 10MR/MIN BY AS MUCH AS .9MR/MIN. ON (B)(6) 2013, THE CE REPORTED THAT HE PERFORMED PATIENT ENTRANCE EXAM DOSE LEVEL ADJUSTMENTS ON BOTH LATERAL AND FRONTAL TUBES AND SET THEM FOR 9.2 TO 9.6 MR/MIN RESPECTIVELY. IT WAS REPORTED THAT THE CUSTOMER'S PHYSICIST CHECKED THE PATIENT ENTRANCE DOSE LEVELS AFTER THE ADJUSTMENT AND FOUND THEM BOTH TO BE LESS THAN 10MR/MIN. PREVIOUS PATIENT ENTRANCE DOSE LEVEL ADJUSTMENTS, AS PART OF SCHEDULED PREVENTATIVE MAINTENANCE, WERE PERFORMED ON THE FRONTAL TUBE ON (B)(6) 2012 AND (B)(6) 2012 FOR THE LATERAL TUBE. THE CUSTOMER SUBMITTED A (B)(4) REPORT FOR THIS INCIDENT. ((B)(4)) NOTE: A MEDWATCH IS ALSO BEING SUBMITTED FOR THE SECOND PATIENT WHO RECEIVED A RADIATION BURN (MEDWATCH 2020563-2013-0003).

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED BY THE HOSPITAL CATHETERIZATION LAB MANAGER THAT ON (B)(6) 2012, A PATIENT ALLEGEDLY RECEIVED RADIATION BURNS ON HIS ARM AND CHEST FROM THE LATERAL X-RAY TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148471 TOSHIBA FLUOROSCOPIC X-RAY SYSTEM MQB TOSHIBA MEDICAL SYSTEMS CORPORATION XIDF-BPS801/A2

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other