BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HITACHI HI VISION 6500

    MDR report key: 532572 · Received March 5, 2004

    Report

    Report Number
    8030405-2004-00001
    Event Type
    Malfunction
    Date Received
    March 5, 2004
    Date of Event
    January 30, 2004
    Report Date
    March 5, 2004
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SITE USES A RADIOLOGY INFO SYSTEM (RIS) TO PASS PT DEMOGRAPHICS TO THE HITACHI EUB-6500 ULTRASOUND SYSTEM. AFTER THE PT EXAM IS COMPLETED, THE IMAGES ARE TRANSFERRED TO A PICTURE ARCHIVE AND COMMUNICATIONS SYSTEM (PACS) FOR STORAGE. THE RIS SYSTEM AND THE PACS SYSTEM ARE MFG BY THIRD PARTIES (RIS LOGIC, INC. AND DYNAMIC IMAGING,INC. RESPECTIVELY). THE EUB-6500 IS CONFIGURED WITH VER. 4.04 SOFTWARE, DICOM WORKLIST AND DICOM SERVICE PACK 1. THE PT FILES ARE ORGANIZED WITHIN FOLDERS ON THE PACS SYSTEM. THE READING RADIOLOGIST ACCESSES THE FILES FROM THE PACS SYSTEM AND MAKES A DIAGNOSIS. ALL DATA TRANSFER BETWEEN THE THREE SYSTEMS (RIS, 6500, PACS) IS ACCOMPLISHED WITH DICOM. BASED ON FILE ANALYSIS, A SMALL NUMBER OF PTS (APPROX 4 OUT OF 100) HAD THEIR IMAGES INTERMIXED WITHIN A FOLDER. FOR EXAMPLE, IMAGES FROM PT A WERE INTERMIXED WITH IMAGES FROM PT B WITHIN THE FOLDER FOR PT A. WITHIN THE FOLDER, THE IMAGES WERE LABELED CORRECTLY. WHEN THE PROBLEM WAS DISCOVERED, THE SITE TOOK STEPS TO NOTIFY THE RADIOLOGIST OF THE PROBLEM. NO PT INJURY OR MIS-DIAGNOSIS HAD OCCURRED. THE PROBLEM WAS REPORTED TO THE DEVICE MFG IN 2004 AFTER IT WAS DETERMINED THAT THE EUB-6500 WAS THE SOURCE OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HITACHI HI VISION 6500 ULTRASOUND DIAGNOSTIC DEVICE KPS HITACHI MEDICAL CORP. EUB-6500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * INTEGRADWEB PACS, DYNAMIC IMAGING, INC.