BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-70C WIRELESS

    MDR report key: 2913815 · Received September 25, 2012

    Report

    Report Number
    1000181430-2012-00042
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Report Date
    July 25, 2012
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Removal / Correction Number
    Z-2265-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED UNIT CONFIRMED THAT THE PANEL HAD LOOSE SCREWS INSIDE. THERE WAS A BURNT (SHORTED) AREA ON THE DC/DC PC BOARD. THE DC/DC PC BOARD WAS REPLACED. THE UNIT WAS SERVICED FOR BOTH LOOSE SCREWS INSIDE THE UNIT AND THE PANEL COVER SCREWS. THE SERVICE REPRESENTATIVE PERFORMED CALIBRATION AND SELF-TESTS, AND THE UNIT MET SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WOULD NOT POWER UP AND THEY CAN HEAR RATTLING INSIDE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1