BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 2233477 · Received September 2, 2011

    Report

    Report Number
    2020563-2011-00017
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    January 22, 2011
    Report Date
    September 2, 2011
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    IZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).ADDITIONAL MANUFACTURER NARRATIVE (IN ADDITION TO NARRATIVE IN ORIGINAL SUBMISSION):SINCE THE SYSTEM IS NOT EQUIPPED WITH THE DOSE METER, IT IS CALCULATED BY THE X-RAY CONDITIONS. THE DOSE CALCULATION RESULT FOR THE PATIENT WITH HAIR LOST IS BELOW.FLUOROSCOPY PULSED FLUOROSCOPY CONDITIONS (THE TYPICAL CONDITION IN THIS CASE) /TUBE VOLTAGE :70KV /TUBE CURRENT : 50MA /PULSE WIDTH : 10MSEC /PULSE RATE: 15FPS / FLUOROSCOPY CUMULATIVE TIME: 20MIN / FLUOROSCOPY CUMULATIVE DOSE (ON THE PATIENT'S SURFACE) : 693.5MGYRADIOGRAPHY RADIOGRAPHY CONDITIONS (THE TYPICAL CONDITION IN THIS CASE) /TUBE VOLTAGE :70KV /TUBE CURRENT : 400MA / PULSE WIDTH: 60MSEC / FRAME RATE :5FPS /THE NUMBER OF RADIOGRAPHY FRAMES: 1107 /RADIOGRAPHY TOTAL DOSE (ON THE PATIENT'S SURFACE) : 2047.21MGY. THE TOTAL DOSE VALUE IS THE SUM OF FLUOROSCOPY CUMULATIVE DOSE AND RADIOGRAPHY TOTAL DOSE. THE TOTAL DOSE VALUE ON THE PATIENT'S SURFACE IS 2740.71MGY.

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EVALUATED BY A TOSHIBA SERVICE ENGINEER, TO INCLUDE RADIATION DOSE. THE SYSTEM WAS FOUND TO BE WITHIN MANUFACTURER'S SPECIFICATION. NO SYSTEM DEFECTS WERE NOTED. THIS REPORT IS BEING FILED AS THE RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS DURING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED DEPILATION OF THE HEAD DURING THE PLACING OF A HEAD CLIPPING COIL. THE USER FACILITY REQUESTED THE EVALUATION OF THE DEVICE BY A TOSHIBA SERVICE ENGINEER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA X-RAY GENERATOR IZO TOSHIBA MEDICAL SYSTEMS CORPORATION KXO-100G

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O