BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-70C WIRELESS

    MDR report key: 2897093 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00120
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    September 21, 2011
    Report Date
    September 30, 2011
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 CANON HEALTHCARE SOLUTIONS USA. GENDER INFO WAS NOT PROVIDED. (B)(4). THE SYSTEM SETTINGS, SOFTWARE AND FIRMWARE VERSIONS, AND THE LOGS WERE REVIEWED. THE CANON USA ENGINEER RECOMMENDED THAT THE SERVICE REPRESENTATIVE UPGRADE THE FIRMWARE. THIS RESOLVED THE PROBLEM. MFR CROSS-REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGES ARE DISAPPEARING. THE TECHNICIAN TAKES AN IMAGE AND IT PROCESSES ON THE GUI, AND THEY CHECK IT TO MAKE SURE IT'S OK. THEN THE TECHNICIAN ENDS THE STUDY AND IT IS AUTOMATICALLY SENT TO THE PACS SYSTEM. THE TECHNICIAN CHECKS TO SEE IF THE IMAGE IS THERE TO CLOSE IT OUT AND THE IMAGE IS NOT THERE. SO THEY GO BACK TO THE MOBILE TO PULL UP THE STUDY AND IT IS NOT THERE EITHER. 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