BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-70C WIRELESS

    MDR report key: 2898929 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00162
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    July 29, 2011
    Manufacturer
    CANON INC.
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 PANEL WAS RETURNED TO CANON INC ((B)(4)). THE PANEL WAS NOT REPAIRABLE. NO OTHER INFO WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGE WAS CORRUPTED. 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-70C WIRELESS MQB CANON INC. CXDI-70C WIRELESS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK