BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-50C

    MDR report key: 2897193 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00221
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    April 27, 2012
    Report Date
    May 2, 2012
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K031447
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 CANNON HEALTHCARE SOLUTIONS USA. (B)(4). THE SERVICE ENGINEER REPLACED THE A/D PC BOARD AND THE FLAT CABLES. HE PERFORMED CALIBRATION AND SELF TESTS. ALL FUNCTIONS WERE CHECKED AND MET SPECS. MANUFACTURER (B)(4).

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE PANEL CONNECTED, ALLOWED EXPOSURE, AND CAPTURED AN IMAGE, BUT THE IMAGE TRANSFER APPEARED TO BE A GRAY, FLAT FIELD WITH NO DATA. TETHER CABLE WAS REPLACED AND PANEL EXHIBITED THE SAME PROBLEM. IT IS POSSIBLE THAT THE IMAGE WA RETAKEN, RESULTING IN UNINTENDED RADIATION EXPOSURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK