BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 2625195 · Received June 21, 2012

    Report

    Report Number
    2020563-2012-00008
    Event Type
    Injury
    Date Received
    June 21, 2012
    Date of Event
    April 29, 2012
    Report Date
    May 4, 2012
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    JAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: TOSHIBA IS CURRENTLY GATHERING ADDITIONAL DATA AND INFORMATION FOR THIS REPORT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO TO THE CAUSE OF THE ALLEGED DIAGNOSIS OF AORTA DISSECTION WAS CONDUCTED BY THE MANUFACTURER. IT WAS FOUND THAT THERE WERE ARTIFACTS ON THE RECONSTRUCTED CT IMAGES. THESE ARTIFACTS WERE DETERMINED TO BE TYPICAL MOTION ARTIFACTS DUE TO PULSATION. NO PROBLEMS WERE FOUND WITH THE CT SYSTEM AND IT OPERATED ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS. WE BELIEVE NO FURTHER INVESTIGATION INTO THIS MATTER IS REQUIRED.

    Description of Event or Problem · 1

    PATIENT HAD A PULMONARY EMBOLISM EXAM. CT IMAGES INDICATED AND RADIOLOGIST DR. (B)(6) CONCURRED, PATIENT WAS POSITIVE FOR AORTA DISSECTION. PATIENT SENT TO SURGERY FOR AORTIC DISSECTION REPAIR. SURGERY PROVED NEGATIVE AORTIC DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK TOSHIBA MEDICAL SYSTEMS CORPORATION TSX-101A/JD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other