BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-70C WIRELESS

    MDR report key: 2897188 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00220
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    April 26, 2012
    Manufacturer
    CANON, INC
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 UPLOADED THE SYSTEM LOGS. HE SUGGESTED THAT THE CUSTOMER UPGRADE THE SOFTWARE TO VERSION 1.40.0 TO RESOLVE THE ISSUE WITH THE EXPOSURE LENGTH. THE UNIT NEEDED A GENERATOR SOFTWARE UPGRADE AS WELL IN ORDER TO SUPPORT VERSION 1.40 AND THE STITCHING FUNCTION. MFR CROSS-REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FIVE ERROR MESSAGES DISPLAYED ON THE SYSTEM. THE ERROR MESSAGES WERE RELATED TO THE IMAGE LENGTH TIME (1 TO 3 SECOND EXPOSURE). THE IMAGES WOULD HAVE BEEN LOST BEFORE THEY WERE TRANSFERRED TO PACS. IT IS POSSIBLE THAT THE IMAGES WERE 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