BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXDI CCS NE VER.2.02.0.16

    MDR report key: 3223844 · Received June 28, 2013

    Report

    Report Number
    1000181430-2013-00113
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    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

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE APPLICATION WAS FROZEN, AFTER PATIENT WAS EXPOSED. NO IMAGE WAS TRANSFERRED FROM THE SENSOR TO THE SYSTEM AND COULD BE DISPLAYED IN MONITOR. PATIENT HAD TO MOVE TO ADJACENT ROOM AND HAVE IMAGE RETAKEN TO COMPLETE THE EXAM. IT WAS RESULTING IN ADDITIONAL RADIATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295295 CXDI CCS NE VER.2.02.0.16 MQB CANON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CXDI-40EC