BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 3051445 · Received April 10, 2013

    Report

    Report Number
    2020563-2013-00003
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 11, 2013
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    KPR
    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)(4) 2013 THAT TWO PATIENTS ALLEGEDLY RECEIVED RADIATION BURNS DURING THEIR EXAMS AND THAT THE PATIENT ENTRANCE DOSE LEVELS ON THE LATERAL TUBE EXCEEDED 10MR/MIN. BOTH EXAMS WERE CONDUCTED BY THE SAME PHYSICIAN. IT WAS REPORTED TO THE CE BY THE CATH LAB MANAGER THAT THE EXAM CONDUCTED ON (B)(6) 2013 WAS APPROXIMATELY 45 MINUTES IN LENGTH AND THE FLUORO TIME WAS APPROXIMATELY 55 MINUTES. THE TOTAL DOSE RECEIVED BY THE PATIENT WAS: FRONTAL - 434 CGYCM2; LATERAL - 2389 CGYCM2. ON (B)(4) 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)(4) 2013, THE CE REPORTED THAT HE PERFORMED PATIENT ENTRANCE EXAM DOSE LEVEL ADJUSTMENTS ON BOTH LATERAL AND FRONTAL AND SET THEM FOR 9.2 TO 9.6 MR/MIN. 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 PATIENT WHO RECEIVED RADIATION BURNS ON (B)(6 2012 (MEDWATCH 2020563-2013-0002).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149929 TOSHIBA FLUOROSCOPIC X-RAY SYSTEM KPR TOSHIBA MEDICAL SYSTEMS CORPORATION XIDF-BPS801/A2

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other