BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON X-RAY DIGITAL CAMERA CXDI-22

    MDR report key: 2897072 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00103
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    April 21, 2010
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K992547
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 SERVICE ENGINEER SWAPPED AND RESEATED THE ANALOG A/D BOARDS BETWEEN TWO LOCATIONS. THE PROBLEM DISAPPEARED. HE ORDERED A SPARE A/D BOARD IN CASE OF FUTURE PROBLEMS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WERE INTERMITTENT IMAGE ARTIFACTS IN ONE QUADRANT OF THE SENSOR PANEL. 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 CANON X-RAY DIGITAL CAMERA CXDI-22 MQB CANON, INC. CXDI-22 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK