BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXDI CONTROL SOFTWARE NE VER. 1.40.2.0

    MDR report key: 2903910 · Received November 28, 2012

    Report

    Report Number
    1000181430-2012-00069
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    CANON, INC.-MEDICAL EQUIPMENT GROUP
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN-PROGRESS. IF ADD¿L INFO 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 DURING THE EXAM, A SYSTEM ERROR MESSAGE DISPLAYED INDICATING REQUIREMENT OF SHUTDOWN THE APPLICATION. AFTER REBOOTING, THE TECH COULD NOT RETRIEVE THE IMAGES OF THIS PATIENT WHICH WERE TAKEN BY PREVIOUS EXPOSURE. THIS PATIENT HAD TO BE RETAKEN, RESULTING IN UNINTENDED RADIATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CXDI CONTROL SOFTWARE NE VER. 1.40.2.0 MQB CANON, INC.-MEDICAL EQUIPMENT GROUP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CXDI-70C DUALBAND