BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXDI-70C

    MDR report key: 3223810 · Received June 28, 2013

    Report

    Report Number
    1000181430-2013-00114
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 THEY HAVE BEEN GETTING ERROR E040300045 WHICH INDICATES DISCONNECTION BETWEEN DETECTOR AND SYSTEM ALMOST DAILY FOR AS FAR BACK AS THE WINDOWS ERROR LOGS GO. DUE TO THIS EVENT, PATIENT HAD TO BE RETAKEN THE IMAGE TO COMPLETE EXAM. IT WAS RESULTING IN ADDITIONAL RADIATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295553 CXDI-70C MQB CANON, INC. CXDI-70C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK