BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-70C WIRELESS

    MDR report key: 2897102 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00137
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    March 23, 2011
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 (B)(4). FEEDBACK FROM CANON INC. (B)(4) CONFIRMED THAT THESE LINES WERE DUE TO THE SAME CAUSE AS OTHER REPORTED EVENTS. WHEN THE DATA TRANSFER IS PERFORMED UNDER POOR COMMUNICATION CONDITIONS, THE DEVICES THAT SEND/RECEIVE THE PACKETS BACK AND FORTH FAIL TO PROCESS THE DATA AND A HORIZONTAL LINE WILL APPEAR ON THE IMAGES. THE CAUSE OF THE PROBLEM IS A BUG IN THE FIRMWARE. AN UPDATED FIRMWARE WAS RELEASED TO FIX THE PROBLEM. FOR SITES WHERE THE PRODUCT IS ALREADY IN SERVICE, THE FIRMWARE WILL BE UPGRADED WHEN CONDUCTING PERIODIC MAINTENANCE, OR IF A CALL IS RECEIVED FROM THE CUSTOMER. THIS IS BECAUSE THE PROBLEM MAY OCCUR DEPENDING ON THE CONDITIONS OF WIRELESS COMMUNICATION AND IN SOME CASES FREQUENCY IS QUITE LOW. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WERE LINES IN THE IMAGES. 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-70C WIRELESS MQB CANON, INC. CXDI-70C WIRELESS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK