BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-70C WIRELESS

    MDR report key: 2680743 · Received July 25, 2012

    Report

    Report Number
    1000181430-2012-00035
    Event Type
    Malfunction
    Date Received
    July 25, 2012
    Date of Event
    April 19, 2012
    Report Date
    July 19, 2012
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CANON INC (B)(4) ISSUED VERSION 2.0 CXDI CONTROL SOFTWARE NE TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    CANON USA, INC. RECEIVED A REPORT THAT INTERMITTENTLY ONE OF THE IMAGES ACQUIRED ON THE CXDI-70C SYSTEM IS BLANK. THE PROBLEM IS OCCURRING WITH VERSION 1.40.2.0 NE SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL RADIOGRAPHY CXDI-70C WIRELESS SOLID STATE X-RAY IMAGER MQB CANON, INC. CXDI-70C WIRELESS NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1