BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXDI-70CW

    MDR report key: 3770302 · Received January 11, 2014

    Report

    Report Number
    1000181430-2014-00004
    Event Type
    Malfunction
    Date Received
    January 11, 2014
    Date of Event
    October 25, 2013
    Report Date
    November 7, 2013
    Manufacturer
    CANON, INC
    Product Code
    MQB
    PMA / PMN Number
    K1202012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GENDER INFO WAS NOT PROVIDED BY REPORTER. THE DATE FOR EVALUATION WAS COLLECTED AND PROVIDED TO MFR. IT WAS FOUND THAT EXCLUSIVE CONTROL FOR MULTIPLE THREADS THAT ARE GENERATED WHEN 1ST PREVIEW IMAGE IS OPERATED WAS INSUFFICIENT. SINCE SPECIFIED OBJECT WAS REFERRED BY THOSE THREADS, THEY MAY REFER TO NULL DEPENDING ON THE OPERATION. DUE TO THIS EXCLUSIVE CONTROL, FAILURE TO CATCH THE EXCEPTION CAUSED SYSTEM DOWN BEFORE THE PROCESS FOR IMAGE CAPTURE IS COMPLETED. THIS EVENT WAS OCCURRED OUTSIDE USA. (B)(4).

    Description of Event or Problem · 1

    THE REPORT OF USER FACILITY STATED AS FOLLOWING:WHEN AN PELVIS IMAGE WAS OPERATED TO ROTATE AFTER EXAM OF CHEST AND PELVIS, DISPLAY BECOME TO BE BLACK AND 3 COMMAND BUTTONS WERE APPEARED. AFTER RESTARTING, THE TECH LOOKED FOR THE IMAGES TAKEN PREVIOUSLY AT FOLDER FOR SAVING IMAGE, ONLY PELVIS IMAGE WAS DISAPPEARED. THE IMAGE WAS RETAKEN, RESULTING IN ADDITIONAL RADIATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22107 CXDI-70CW MQB CANON, INC CXDI-70CW NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CONTROL SOFTWARE NE V1.30.0