BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY CXDI-70C WIRELESS

    MDR report key: 2897197 · Received December 31, 2012

    Report

    Report Number
    1000181430-2012-00226
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    May 15, 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
    KS, 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 CANNON HEALTHCARE SOLUTIONS USA. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBSERVED ERROR MESSAGE CODES. THE PANEL WAS RETURNED AND SERVICED FOR THE LOOSE SCREW ISSUE.

    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