BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-50G WIRELESS

    MDR report key: 2897070 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00118
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    October 22, 2010
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K031447
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. (B)(4). THE SENSOR WAS NEVER RETURNED. THE CUSTOMER ADVISED THAT THE ANALOG/DIGITAL PRINTED WIRING BOARD MAY BE DEFECTIVE. NO SUBSEQUENT INFO WS PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HALF OF THE IMAGE WAS CUT OFF. 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 WIRELESS MQB CANON, INC. CXDI-50G WIRELESS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK