BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-70C WIRELESS

    MDR report key: 2897191 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00222
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    May 3, 2012
    Manufacturer
    CANON, INC
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 DETERMINED THAT THE SENSOR HAD AN OLDER VERSION OF THE SOFTWARE AND FIRMWARE. THE PROBLEM WAS RESOLVED BY INSTALLING THE LATEST FIRMWARE AND UPGRADING THE SOFTWARE TO VERSION 1.4 OR HIGHER. A SERVICE UPDATE WAS ISSUED TO REPLACE THE FIRMWARE IN THE SENSOR PANELS. THE DEALERS HAVE BEEN NOTIFIED. THE SERVICE REP WILL UPDATE THE FIRMWARE OF THE CUSTOMERS DURING ROUTINE SERVICE CALLS AND AS PROBLEMS ARE REPORTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INTERMITTENTLY, AN IMAGE LOOKS "LAYERED" AND THAT THE EXPOSURE HAS TO BE REPEATED. THE REPEATED EXPOSURE WOULD HAVE RESULTED 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