BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-70C WIRELESS

    MDR report key: 2980384 · Received January 28, 2013

    Report

    Report Number
    1000181430-2013-00032
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    April 26, 2011
    Manufacturer
    CANON INC.
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GENDER INFORMATION WAS NOT PROVIDED. (B)(4). THE SERIAL NUMBER OF THE SENSOR PANEL WAS NOT PROVIDED. THE DEALER SERVICE REPRESENTATIVE SWAPPED COMPUTERS WITH A DEMO UNIT AND THE PROBLEM STILL OCCURRED. THE HARD DRIVE WAS REPLACED AND THE SYSTEM WAS OK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS NOT TRANSFERRING THE IMAGE FROM THE CXDI-70C WIRELESS PANEL TO THE COMPUTER . THE COMPUTER WAS LOCKING UP WHILE CAPTURING AND JUST HANDING THERE. IT IS POSSIBLE THAT THE IMAGE WAS RETAKEN, RESULTING IN UNINTENDED RADIATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37142 DIGITAL RADIOGRAPHY CXDI-70C WIRELESS MQB CANON INC. CXDI-70C WIRELESS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 545 NE-00R COMPUTER