BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXDI-70C

    MDR report key: 3112214 · Received May 1, 2013

    Report

    Report Number
    1000181430-2013-00066
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INVESTIGATION IS STILL IN-PROGRESS. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED PER 21CFR 803.56. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE 3/4 INCH LINE ACROSS MIDDLE OF IMAGE. IT IS POSSIBLE THAT THE IMAGE WAS RETAKEN, RESULTING IN UNINTENDED RADIATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190916 CXDI-70C MQB CANON, INC. CXDI-70C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK