BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-70C WIRELESS

    MDR report key: 2897156 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00155
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    June 20, 2011
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Removal / Correction Number
    Z-2265-2012
    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 DEALER OPENED THE SENSOR PANEL AND FOUND THAT THERE WERE LOOSE SCREWS INSIDE THE PANEL. THE UNIT WAS REPAIRED FOR THE LOOSE SCREW ISSUE. THE PANEL WAS CALIBRATED AND SELF TESTS WERE PERFORMED TO ASSURE PROPER FUNCTION. (B)(4).

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT TWO ERROR MESSAGES DISPLAYED ON THE UNIT. EVAL OF THE RETURNED PRODUCT FOUND THAT THERE WERE LOOSE SCREWS INSIDE THE PANEL.

    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 NA