BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-50G

    MDR report key: 2897195 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00223
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    May 4, 2012
    Manufacturer
    CANON, INC
    Product Code
    MQB
    PMA / PMN Number
    K031447
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 EVALUATED THE SENSOR AND FOUND THAT ALL FOUR SHOCK SENSORS WERE TRIPPED OR MISSING. TWO CLAMPS WERE MISSING ON THE EXTERIOR OF THE UNIT. THE FRONT AND BACK COVERS HAD SCRATCHES AND RESIDUE ON THEM. THE ISOLATION SLEEVES WERE MISSING. THERE WERE NO SIGNS OR IMPACT OR LIQUID RESIDUE INSIDE THE UNIT. THE ANALYSIS FOUND THAT THE INTERNAL TCP-A LANMIT (TAB) WAS DAMAGED AND WAS NOT REPAIRABLE. THIS DAMAGE CAUSED ONLY THE ODD NUMBERED OF VERTICAL ROWS TO BE NORMAL. MANUFACTURER CROSS-REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BAR ARTIFACT. 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-50G MQB CANON, INC CXDI-50G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK