BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-55G

    MDR report key: 2897181 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00216
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    April 20, 2012
    Manufacturer
    CANON, INC
    Product Code
    MQB
    PMA / PMN Number
    K091435
    Removal / Correction Number
    Z-2265-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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). EVAL OF THE RETURNED UNIT FOUND THAT ALL FOUR SHOCK SENSORS WERE TRIPPED. THE OUTSIDE EDGES OF THE PANEL HAD SCRATCHES, GOUGES, AND CUTS. THE SUPPORT CONE WAS DEFORMED DUE TO REPEATED SHOCKS, CAUSING THE METAL TO BE BENT. TWO INTERNAL SCREWS HAD BECOME LOOSE AND WERE FOUND INSIDE THE SENSOR. AN INDENTATION FROM A LOOSE SCREW WAS FOUND ON THE BACK SIDE OF THE SENSOR GLASS. THE SENSOR TAB ON THE TCP-D WAS DAMAGED. THE ANALYSIS RESULTS STATED THAT THE IMAGE ARTIFACT WA DUE TO THE TCP-D DAMAGES, POSSIBLE CAUSE BY THE LOOSE SCREWS. MFR CROSS-REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WERE VISIBLE ARTIFACTS ON THE IMAGE AT THE VERY END OF THE PANEL WHEN FULLY EXPOSED. IT IS POSSIBLE THAT THE IMAGE WAS RETAKEN, RESULTING IN UNINTENDED RADIATION EXPOSURE. THE RETURNED PANEL WAS ALSO REPAIRED FOR A LOOSE SCREW ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK