BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-55G

    MDR report key: 2897166 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00211
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    March 23, 2012
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K091435
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 PANEL WAS RETURNED AND TESTING FOUND AN INTERMITTENT PLD ERROR. THE SERVICE ENGINEER REPLACED THE DI PC BOARD, SIDE COVERS AND BOTTOM COVERS. THE AC ADAPTER WAS ALSO CHANGED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGES WERE LIGHT AND WASHED OUT. 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-55G MQB CANON, INC. CXDI-55G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK