BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXDI CONTROL SOFTWARE NE VER.1.40 AND 1.40.1

    MDR report key: 2680744 · Received July 25, 2012

    Report

    Report Number
    1000181430-2012-00034
    Event Type
    Malfunction
    Date Received
    July 25, 2012
    Date of Event
    November 14, 2011
    Report Date
    July 19, 2012
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CANON INC. (B)(4) ISSUED VERSION (B)(4) NE CXDI CONTROL SOFTWARE ON 11/16/2011 TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    CANON U.S.A., INC. MEDICAL SYSTEMS DIVISION (CMS) RECEIVED A REPORT OF GRAYED OUT OR BLANK IMAGES WITH CXDI-70C WIRELESS PANEL USED IN CONJUNCTION WITH NE CONTROL SOFTWARE VERSION (B)(4). UPON INVESTIGATION, IT WAS FOUND THAT IMAGES WOULD APPEAR GRAY OR BLANK WHEN SENT TO THE PACS AND WERE STORED THAT WAY IN THE PAST STUDY LIST ON THE NE SOFTWARE. THE BLANK IMAGES WERE UNUSABLE AND NECESSITATED RETAKING IMAGES, WHICH WOULD SUBJECT PTS TO UNNECESSARY ADDITIONAL RADIATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CXDI CONTROL SOFTWARE NE VER.1.40 AND 1.40.1 CONTROL SOFTWARE MQB CANON, INC. NE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT AVAILABLE