BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-55G WIRELESS

    MDR report key: 2897075 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00106
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    July 9, 2010
    Manufacturer
    CANON INC.
    Product Code
    MQB
    PMA / PMN Number
    K091435
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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). CANON INC PERFORMED TESTING AND FOUND THAT THREE SHOCK SENSORS WERE TRIPPED. CANON INC INSTALLED A NEW DI BOARD AND ERROR WAS SOLVED. WHEN THE ORIGINAL DI BOARD WAS RE-INSTALLED INTO THE SENSOR THE REPORTED ERROR CODE RETURNED. IT WAS CONCLUDED THAT THE ERROR WAS CAUSED BY THE DAMAGE DI BOARD. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A READ IMAGE ERROR DISPLAYED ON THE SYSTEM. IT IS POSSIBLE THAT THE IMAGE WAS RETAKEN, RESULTING IN ADDITIONAL RADIATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL RADIOGRAPHY CXDI-55G WIRELESS MQB CANON INC. CXDI-55G WIRELESS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK