BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESIUS 190 XPRES

    MDR report key: 1509706 · Received October 13, 2009

    Report

    Report Number
    1509706
    Event Type
    Malfunction
    Date Received
    October 13, 2009
    Date of Event
    October 12, 2009
    Report Date
    October 12, 2009
    Manufacturer
    KONICA-MINOLTA MEDICAL IMAGING USA, INC.
    Product Code
    IWZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OF THE 108 PLATES PUT INTO USE, 60 PLATES HAVE DEVELOPED FLAWS OR ARTIFACTS. THESE ARTIFACTS IF NOT DETECTED COULD RESULT IN ADDITIONAL DIAGNOSTIC TESTING AND POTENTIAL HARM.BEGINNING IN SEPT 2007, THIS FACILITY RETURNED 28 OF THE 43 14" X 17" PLATES UNDER WARRANTY TO KONICA AND RECEIVED REPLACEMENT. SUBSEQUENTLY, AN ADDITIONAL 41 PLATES WERE FOUND TO BE FLAWED. KONICA TOLD THIS HOSPITAL THAT NO OTHER FACILITIES HAVE REPORTED THIS TYPE OF ISSUE.THE ARTIFACT ON THE IMAGING PLATES APPEARS AS A SMALL AREA(S) OF HIGHER ATTENTUATION THAT CAN BE MISTAKEN FOR CALCIFICATION.WE BELIEVE THAT THE CAUSE MAY BE CHIPS OF GLUE WHICH FALL BETWEEN THE COVER AND THE IMAGED STORAGE PLATE. THE GLUE IS USED TO HOLD THE METAL FRAME SURROUNDING THE CASSETTE.

    Description of Event or Problem · 1

    OF THE 108 PLATES PUT INTO USE, 60 PLATES HAVE DEVELOPED FLAWS OR ARTIFACTS. THESE ARTIFACTS IF NOT DETECTED COULD RESULT IN ADDITIONAL DIAGNOSTIC TESTING AND POTENTIAL HARM.BEGINNING IN SEPT 2007, THIS FACILITY RETURNED 28 OF THE 43 14" X 17" PLATES UNDER WARRANTY TO KONICA AND RECEIVED REPLACEMENT. SUBSEQUENTLY, AN ADDITIONAL 41 PLATES WERE FOUND TO BE FLAWED. KONICA TOLD THIS HOSPITAL THAT NO OTHER FACILITIES HAVE REPORTED THIS TYPE OF ISSUE.THE ARTIFACT ON THE IMAGING PLATES APPEARS AS A SMALL AREA(S) OF HIGHER ATTENTUATION THAT CAN BE MISTAKEN FOR CALCIFICATION.WE BELIEVE THAT THE CAUSE MAY BE CHIPS OF GLUE WHICH FALL BETWEEN THE COVER AND THE IMAGED STORAGE PLATE. THE GLUE IS USED TO HOLD THE METAL FRAME SURROUNDING THE CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESIUS 190 XPRES IMAGING PLATE, COMPUTED RADIOGRAPHY IWZ KONICA-MINOLTA MEDICAL IMAGING USA, INC. RESIUS 190 XPRESS *

    Patients

    Seq Age Sex Outcome Treatment
    1 *