BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-55C

    MDR report key: 2897114 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00121
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    November 30, 2010
    Manufacturer
    CANON, INC. - MEDICAL EQUIPMENT GROUP
    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 SERVICE REPRESENTATIVE REPLACED A DEFECTIVE DI PC BOARD. 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 A READ IMAGE ERROR OCCURRED WITH THE PANEL. 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. - MEDICAL EQUIPMENT GROUP CXDI-55C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK