BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5T SIGNA HDXT

    MDR report key: 2013401 · Received February 1, 2011

    Report

    Report Number
    2183553-2011-00005
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 3, 2011
    Report Date
    February 1, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SITE REPORTED THAT SCREEN SAVED IMAGES FROM THE MR SYSTEM ARE ATTACHING TO THE INCORRECT PT ON THE PACS SYSTEM. THE TECHNOLOGIST WILL REPORTEDLY SEND A SCREEN SAVE IMAGE FROM THE MR (MAGNETIC RESONANCE) SYSTEM TO THE PACS (PICTURE ARCHIVE COMMUNICATION SYSTEM). THE SCREEN SAVE IS THEN ATTACHED TO THE CORRECT EXAM ON THE MR SYSTEM., HOWEVER ON THE PACS, THE SCREEN SAVE MAY ATTACH TO A DIFFERENT PT/EXAM. NO INJURY HAS BEEN REPORTED. THE WORKFLOW AT THE SITE IS FOR THE TECHNOLOGIST TO REVIEW THE EXAM ON PACS, TO VERIFY ALL THE IMAGES HAVE ARRIVED TO PACS AND ARE CORRECT. THE TECHNOLOGIST WILL THEN MARK THE EXAM VERIFIED WHICH WILL MOVE THE EXAM TO THE UNREAD WORKLIST ON THE PACS SYSTEM FOR THE RADIOLOGIST TO REVIEW. INITIAL EVALUATION INDICATES THAT THE ISSUE IS CAUSED WHEN THE MR SYSTEM REPLICATES THE SERIES INSTANCE UID (0X0020, 0X000E) BETWEEN THE TWO SCREEN SAVE IMAGES. HOWEVER, THE TWO SCREEN SAVE IMAGES BOTH ARE USING THE SAME SERIES INSTANCE UID (0020, 000E). GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5T SIGNA HDXT MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1