BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAM CXDI-55G

    MDR report key: 2482721 · Received February 27, 2012

    Report

    Report Number
    1000181430-2012-00002
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    April 26, 2010
    Report Date
    February 27, 2012
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K091435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFO NEED TO BE MADE AS COUNTERMEASURES. SCREW TYPE (FOR THE TWO LOCATIONS) NEED TO BE CHANGED FROM L = 4MM TO 6MM + WASHER + SPRING WASHER. SCREW TIGHTENING TORQUE NEED TO BE INCREASED FROM 3KGF CM TO 4KGF CM. THREAD LOCKING NEED TO BE APPLIED TO THE SCREW HEAD AND PCB.

    Description of Event or Problem · 1

    SCREWS HOLDING THE 55REF CIRCUIT BOARD ARE LOOSENING AND ROAMING INSIDE OF THE SEALED SENSOR. THIS CAN ALSO CAUSE THE CIRCUIT BOARD TO SHORT CIRCUIT, CAUSE IMAGE FAILURE, AND ERROR INTERMITTENTLY. IN SOME CASES, IT CAN CAUSE THE BOARD TO PERMANENTLY FAIL. WITH IMAGE FAILURE, IT COULD CAUSE EXCESSIVE RADIATION EXPOSURE TO THE PT WITH NO RESULTING IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL RADIOGRAM CXDI-55G SOLID STATE X-RAY IMAGER MQB CANON, INC. CXDI-55G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other