BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXDI CCS NE VER.1.40.2

    MDR report key: 3150002 · Received May 17, 2013

    Report

    Report Number
    1000181430-2013-00090
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 19, 2013
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THAT WAS A SAME ERROR WHICH WE HAVE EXPERIENCED AND ANALYZED IN THE PAST. THIS ERROR CAUSED BY THE TIMING AT WHICH CONNECTING OR DISCONNECTING WITH MEMORY IS PROCESSED WHEN EXPOSURES ARE TAKEN AND THE TIMING AT WHICH THE PREVIEW IMAGE ARE STORED. IT WAS RESULTED IN FAILURE TO STORE RAW IMAGES. THE PROBLEM HAS BEEN CORRECTED IN A SUBSEQUENT SOFTWARE UPGRADE (VERSION 2.02). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERROR E050600002 IMAGE FILE READING FAILED DURING OUTPUT IMAGE GENERATION. A TOTAL OF 5 IMAGES WERE LOST. THE DATA WAS AMONG 3 PTS; 1 IMAGE LOST ON ONE PT, 2 IMAGES LOST ON THE OTHER 2 PTS. THE PTS HAD TO HAVE THE IMAGES REPEATED. THE IMAGE WAS RETAKEN, RESULTING IN ADDITIONAL RADIATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219555 CXDI CCS NE VER.1.40.2 MQB CANON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CXDI-70C WIRELESS