BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNGO IMAGING

    MDR report key: 2556153 · Received April 23, 2012

    Report

    Report Number
    2240869-2012-00032
    Event Type
    Malfunction
    Date Received
    April 23, 2012
    Date of Event
    March 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IZH
    PMA / PMN Number
    K042095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE IS UNDER INVESTIGATION IN THE FACTORY PRESENTLY THERE IS NO RCA (ROOT CAUSE ANALYSIS) COMPLETED. THE FACTORY IS ATTEMPTING TO RECOVER THE LOST IMAGES AND DATA AND HAS BEEN SUCCESSFUL IN FINDING THE 2011 MISSING STUDIES. THIS WAS POSSIBLE BECAUSE THE COPY TAPES FROM 2011 WERE FOUND AND THE DATA WAS RESTORED FROM THEM. THE COPY TAPES FROM 2009 HAVE BEEN LOST OR DESTROYED. THE MIGRATION SCRIPT IS BEING CHECKED AND THE PROCESS FOR MIGRATING DATA IS BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED TO THE AGENCY WHEN MORE INFO BECOMES AVAILABLE. AS AN IMMEDIATE MEASURE ALL SITES WHICH HAVE BEEN MIGRATED IN THE PAST, AS WELL AS ONGOING MIGRATIONS, ARE BEING INVESTIGATED FOR COMPLETENESS. NEW MIGRATIONS ARE ON HOLD UNTIL THE INVESTIGATION IS COMPLETED AND THE RCA OF THE MISSING IMAGES IS FINALIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DATA LOSS OCCURRED AFTER A MIGRATION WAS PERFORMED. IN (B)(6) 2012, THE CUSTOMER SWITCHED FROM AN IBM TAPE LIBRARY TO AN EMC SPINNING DISC SOLUTION. UNTIL RECENTLY NO ISSUES HAD BEEN REPORTED ABOUT THE INABILITY TO PREFETCH NEARLINE DATA THAT WAS MOVED DURING THE ABOVE MIGRATION. THE LOST DATA WAS FROM 2009 (PARTIAL LOSS) AND 2011 (ALSO PARTIAL LOSS). THE DATA LOSS APPEARS TO HAVE OCCURRED WHEN MIGRATION FROM TAPE TO DISC WAS PERFORMED, BUT CANNOT BE CONFIRMED AT THIS TIME. THERE HAVE BEEN NO INJURIES ATTRIBUTED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNGO IMAGING SYSTEM, IMAGE PROCESSING, RADIOLOGICAL IZH SIEMENS MEDICAL SOLUTIONS USA, INC. 10496226 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other