BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIT SYSTEMS

    MDR report key: 951144 · Received November 15, 2007

    Report

    Report Number
    MW5004452
    Event Type
    Malfunction
    Date Received
    November 15, 2007
    Report Date
    November 14, 2007
    Manufacturer
    BRIT SYSTEMS, INC
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BECAUSE OF A COMPUTER CODE PROBLEM INVOLVING RECONCILIATION OF DATA BETWEEN SERVERS, WE KNOW THAT AT LEAST 1305 IMAGES AND RELATED PT DATA OF 520 PATIENTS WERE AUTOMATICALLY AND ERRONEOUSLY DELETED FROM OUR BRIT PACS ARCHIVE OVER A PERIOD OF ABOUT TWO YEARS. THIS DATA LOSS OCCURRED WITH TRANSFER OF PT DATA BETWEEN TWO DIVISIONS OF THE VA PUGET SOUND HEALTH CARE SYSTEM, BUT WAS PROPAGATED TO A CENTRAL ARCHIVE SERVING TWO OTHER VA MEDICAL CENTERS IN AN INTEGRATED SYSTEM. THE POSSIBILITY OF ADDITIONAL DATA LOSS AT PUGET SOUND AND/OR THE OTHER MEDICAL CENTERS IS BEING INVESTIGATED. UPON DISCOVERY, THE PRESUMED MAL-FUNCTIONING COMPUTER SCRIPT HAS BEEN STOPPED, IN-DEPTH ANALYSIS OF THE PROBLEM BY THE VA AND THE VENDOR IS UNDERWAY, AND METHODS OF DATA RESTORATION FROM A VA ARCHIVE ARE BEING DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIT SYSTEMS PACS LLZ BRIT SYSTEMS, INC RELEASE 3.1.01

    Patients

    Seq Age Sex Outcome Treatment
    1 YR