BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-55C

    MDR report key: 2897144 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00213
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    April 4, 2012
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K091436
    Removal / Correction Number
    NA
    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 CANON HEALTHCARE SOLUTIONS USA. GENDER INFO WAS NOT PROVIDED. (B)(4). THE SENSOR PANEL WAS RETURNED FOR EVALUATION. THE SERVICE ENGINEER REPLACED THE DI PC BOARD. HE ALSO REPLACED THE COVER UNIT, SIDE COVERS, AND BOTTOM COVERS. THE PANEL WAS SERVICED FOR EXTERIOR PANEL SCREW TORQUE. HE PERFORMED THE CALIBRATION AND SELF TESTS, AND ALL FUNCTIONS MET SPECIFICATIONS. MFR CROSS-REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WERE LINE ARTIFACTS ON THE IMAGE. TWO ERROR CODES ALSO DISPLAYED ON THE SYSTEM. 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-55C MQB CANON, INC. CXDI-55C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK