BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-50G

    MDR report key: 2897125 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00138
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    April 5, 2011
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K031447
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED RETROACTIVELY AS A RESULT OF AN INTERNAL AUDIT OF COMPLAINT FILES CONDUCTED BY CANON HEALTHCARE SOLUTIONS USA. (B)(4). THE CUSTOMER DATA WAS UPLOADED BY THE CANON USA SERVICE ENGINEER. THE PROBLEM WAS INTERMITTENT. ANALYSIS OF THE DATE INDICATED THAT THE PROBLEM WAS WITH THE A/D PC BOARD OR THE CONNECTING RIBBON CABLES. THE ENGINEER RECOMMENDED THAT THE CUSTOMER RETURN THE SENSOR PANEL FOR REPAIR. THE DECISION WAS MADE NOT TO REPAIR THE PANEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HALF OF THE IMAGE WAS DARK. THE CUSTOMER UPLOADED THE IMAGE FOR REVIEW. THE IMAGE DENSITY CHANGED ABRUPTLY AT A DIFFERENT LOCATION IN THE IMAGE. THERE WAS ALSO A DAMAGED PIXEL LINE. IT IS POSSIBLE THAT THE IMAGE WAS RETAKEN, RESULTING IN UNINTENDED RADIATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL RADIOGRAPHY CXDI-50G MQB CANON, INC. CXDI-50G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK