BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNA OVATION 5

    MDR report key: 2066171 · Received March 29, 2011

    Report

    Report Number
    9613445-2011-00003
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO.
    Product Code
    LNH
    PMA / PMN Number
    K053009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING INVESTIGATION OF THE EVENT ASSOCIATED WITH MDR 2183553-2011-00005, IT WAS DISCOVERED INTERNALLY THAT THE OVATION 5 IS ALSO AFFECTED BY THE REPORTED ISSUE. THERE WAS NO PATIENT INVOLVEMENT FOR THE INTERNALLY DISCOVERED ISSUE. SCREEN SAVED IMAGES FROM THE MAGNETIC RESONANCE (MR) SYSTEM WILL ATTACH TO THE INCORRECT PATIENT ON THE PICTURE ARCHIVE COMMUNICATION SYSTEM (PACS). WHEN THE USERS SEND A SCREEN SAVE IMAGE FROM THE MR SYSTEM TO THE PACS, 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 PATIENT/EXAM. 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 FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA OVATION 5 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM LNH GE HANGWEI MEDICAL SYSTEMS CO.

    Patients

    Seq Age Sex Outcome Treatment
    1