BEUDAMED
    FDA Adverse Event Summary report: N

    TOSHIBA

    MDR report key: 2182114 · Received July 28, 2011

    Report

    Report Number
    2020563-2011-00013
    Date Received
    July 28, 2011
    Date of Event
    May 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    TOSHIBA MEDICAL SYSTEM CORPORATION
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP ULTRASOUND AND SUBSEQUENT HELICAL CT SCAN OF THE CHILD'S BRAIN SHOWED THERE WAS NO BLEED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER FOR THE MANUFACTURER'S INVESTIGATION. METHOD: (B)(4) INVESTIGATION IS SCHEDULED TO BEGIN AS SOON AS THE ADDITIONAL INFORMATION REQUESTED BY THE MANUFACTURER HAS BEEN RECEIVED. RESULTS (B)(4) NO RESULTS UNTIL THE CONCLUSION OF THE INVESTIGATION. CONCLUSIONS (B)(4) NO CONCLUSIONS UNTIL THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A CHILD (UNKNOWN AGE) WAS SCANNED (B)(6) 2011, USING VOLUME MODE ON THE CHILD'S BRAIN. THE TAMS EMPLOYEE WAS TOLD THAT THE STUDY WAS INTERPRETED AS A BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA SYSTEM, X-RAY TOMOGRAPHY, COMPUTED JAK TOSHIBA MEDICAL SYSTEM CORPORATION TSX-301A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other