BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-70C WIRELESS

    MDR report key: 2897139 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00153
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    June 14, 2011
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K102012
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 (B)(4). GENDER INFO WAS NOT PROVIDED.(B)(4). THE CAUSE OF THE LOST IMAGES WAS THAT THE DEALER SERVICE REPRESENTATIVE DID NOT FOLLOW PROTOCOL FOR RESOLVING THE DATABASE ERROR. HE RESTORED THE DATABASE AND THE MOST RECENT IMAGES WERE NO LONGER AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY COULDN'T RETRIEVE THE PT'S IMAGES. THE SYSTEM HAD A DATABASE ERROR. THE DEALER SERVICE REPRESENTATIVE RESTORED THE DATABASE AND THE MOST RECENT IMAGES WERE NO LONGER AVAILABLE. THE IMAGES WERE LOST. IT IS POSSIBLE THAT THE IMAGE WAS RETAKEN, RESULTING IN UNINTENDED RADIATION EXPOSURE.

    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 UNK