BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-55C

    MDR report key: 2897136 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00149
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    May 14, 2011
    Report Date
    May 16, 2011
    Manufacturer
    CANON, INC
    Product Code
    MQB
    PMA / PMN Number
    K091436
    Removal / Correction Number
    Z-2265-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED RETROACTIVELY AS A RESULT OF AN INTERNAL AUDIT OF COMPLAINT FILES CONDUCTED BY CANNON HEALTHCARE SOLUTIONS USA. (B)(4). THE SERVICE REP REPLACED THE REF PC BOARD. HE ALSO PERFORMED REPAIRS DUE TO THE LOOSE SCREW ISSUE. THE SERVICE REP PERFORMED THE CALIBRATION AND SELF TESTS, AND ALL FUNCTIONS MET SPECS. MFR CROSS-REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT HIGH REX VALUES THAT OCCUR WITH L-SPINE IMAGES IN THE OPERATING ROOM. THE PROBLEM OCCURS AFTER DISCONNECTING AND RECONNECTING THE PANEL. THE TECH SHOOTS A KNOWN GOOD EXPOSURE FOR L-SPINE, AND THEN GETS AN EXTREMELY HIGH REX VALUE. THE PROBLEM EXISTS FOR THE NEXT EXPOSURES UNTIL THEY REMOVE THE UNIT FROM THE OPERATING ROOM. IT IS POSSIBLE THAT THE IMAGES WERE RETAKEN, RESULTING IN UNINTENDED RADIATION EXPOSURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK