BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILHOUETTE (PROMINENCE,DYNAVISION,VRS/APP)

    MDR report key: 91455 · Received May 14, 1997

    Report

    Report Number
    8022142-1997-00001
    Event Type
    Malfunction
    Date Received
    May 14, 1997
    Date of Event
    April 15, 1997
    Report Date
    May 13, 1997
    Manufacturer
    I.S.G. TECHNOLOGIES, INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CO HAS DETECTED A PROBLEM RELATED TO THE TRANSFERRING OF IMAGES TO SILHOUETTE WHEN THE DISK IS FULL. THIS PROBLEM HAS NOT BEEN REPORTED FROM THE FIELD, BUT WAS DISCOVERED DURING ROUTINE INTERNAL TESTING. CO'S INTERNAL ASSESSMENT IS THAT THE PROBABILITY OF SAFETY RELATED PROBLEMS OCCURRING DUE TO THIS PROBLEM IS HIGHLY REMOTE. THE PROBLEM OCCURS WHEN THE DISK IS FULL WHILE THE DICOM SERVER IS ATTEMPTING TO STORE INCOMING IMAGES IN THE DATABASE. THE IMAGES HAVE A COMPLETE IMAGE HEADER, BUT PIXEL DATA IS EITHER MISSING OR INCOMPLETE. WHEN THE USER TRIES TO DISPLAY OR PRINT THESE IMAGES, THE VIEWPORT WILL HAVE THE CORRECT IMAGE HEADER INFO, BUT THE IMAGE WILL BE EITHER BLANK, HAVE RANDOM NOISE, HAVE FRAGMENTS OF OTHER IMAGES, OR COMPLETE IMAGES FROM ANOTHER PT. THE POTENTIAL SAFETY PROBLEM IS IN THE LAST CASE WHERE COMPLETED IMAGES FROM ANOTHER PT ARE DISPLAYED AS THE PT UNDER REVIEW. THE LIKELIHOOD THAT COMPLETE IMAGES WILL BE DISPLAYED WITHOUT OTHER VISIBLE ARTIFACTS (E.G. BLANK VIEWPORTS, FRAGMENTS OR NOISE) IS HIGHLY UNLIKELY, AND IT IS EVEN MORE UNLIKELY THAT THE EXACT ANATOMICAL LOCATION AND IMAGE CHARACTERISTICS MATCH WITH THE PT'S OTHER IMAGES. HENCE, USERS NEED TO BE INFORMED, BUT THE LIKELIHOOD IS VERY REMOTE THAT A SAFETY INCIDENT WOULD OCCUR. NOTE THAT THIS PROBLEM HAS NOT BEEN REPORTED FROM THE FIELD, WHERE THE SOFTWARE HAS BEEN IN USE FOR ABOUT TEN MONTHS. IT WAS DISCOVERED ON THE MFR'S PREMISES DURING ROUTINE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE (PROMINENCE,DYNAVISION,VRS/APP) IMAGE PROCESSING SYSTEM LLZ I.S.G. TECHNOLOGIES, INC. DYNAVISION V1,V1.0.1(MORE) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *