BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-55C

    MDR report key: 2897163 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00208
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    March 21, 2012
    Manufacturer
    CANON, INC.
    Product Code
    MQB
    PMA / PMN Number
    K091436
    Removal / Correction Number
    NA
    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 CANON HEALTHCARE SOLUTIONS USA. GENDER INFO WAS NOT PROVIDED. (B)(4). THE CUSTOMER WAS ADVISED TO PROVIDE THE IMAGE FROM DSTORE AND LOG FILES. THE DEALER WAS GIVEN TROUBLESHOOTING MEASURES, BUT THE PROBLEM HAS NOT REOCCURRED. A NEW FIRMWARE WAS RELEASED TO CORRECT THIS PROBLEM. REMEDIAL ACTION INFORMATION PROVIDED. A SERVICE UPDATE WAS ISSUED TO REPLACE THE FIRMWARE IN THE SENSOR PANELS. THE DEALERS HAVE BEEN NOTIFIED. THE SERVICE REPRESENTATIVES WILL UPDATE THE FIRMWARE OF THE CUSTOMERS DURING ROUTINE SERVICE CALLS AND AS PROBLEMS ARE REPORTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGE WAS CORRUPTED WHEN IT WAS SENT TO PACS. THE IMAGE LOOKED LIKE FOUR BARS, WHITE AND BLACK. 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-55C MQB CANON, INC. CXDI-55C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK