BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXDI - 55C

    MDR report key: 3535878 · Received October 29, 2013

    Report

    Report Number
    1000181430-2013-00139
    Event Type
    Malfunction
    Date Received
    October 29, 2013
    Report Date
    September 4, 2012
    Manufacturer
    CANON, INC
    Product Code
    MQB
    Removal / Correction Number
    Z-2265-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS EVALUATED BY CANON U.S.A. WE FOUND THE LOOSE SCREW FROM PCB-D FLOATING AROUND AND CAUSING IMAGE ARTIFACTS. THE SERVICE REP RESEATED THE SCREW AND REPAIRED AS PER SERVICE MANUAL REPORT WHICH WAS RELEASED FROM MFR FOR PERFORMING COUNTERMEASURE OF THIS PROBLEM. THE SENSOR WAS PERFORMED CALIBRATION/SELF TEST AND CHECKED ALL FUNCTIONS TO FACTORY SPECS. CANON INC INFORMED THIS EVENT FROM CANON U.S.A. AT (B)(6) 2013. CANON U.S.A. STATED INITIALLY WHEN THIS COMPLAINT WAS OPENED AND EVALUATED FOR MDR REPORTABILITY, IT WAS NOT DETERMINED TO BE MDR REPORTABLE. HOWEVER, THEY CHANGED THEIR DECISION WHEN THEY BECAME TO KNOW THE ACTION OF SERVICE ENGINEER TO SOLVE THIS EVENT. THEREFORE, WE SUBMIT THIS MDR RETROACTIVELY. MFR CROSS-REFERENCE #(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED IMAGES ARE GETTING HORIZONTAL LINES ACROSS INTERMITTENTLY. IT IS POSSIBLE THAT THE IMAGE WAS RETAKEN, RESULTING IN ADD'L RADIATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555782 CXDI - 55C MQB CANON, INC CXDI-55C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK