BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXDI CONTROL SOFTWARE NE VERSION 1.40.2

    MDR report key: 2945430 · Received February 1, 2013

    Report

    Report Number
    1000181430-2013-00035
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    December 31, 2012
    Report Date
    February 1, 2013
    Manufacturer
    CANON INC.
    Product Code
    MQB
    PMA / PMN Number
    K062221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AFTER FIRST EXPOSURE, TECHNICIAN GOT AN IMAGE WITH NO ANATOMY. PORTABLE MACHINE WAS RESTARTED, A TEST EXPOSURE WAS TAKEN, AND EXAM WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45038 CXDI CONTROL SOFTWARE NE VERSION 1.40.2 CONTROL SOFTWARE MQB CANON INC. NE

    Patients

    Seq Age Sex Outcome Treatment
    1 CXDI-70C WIRELESS