BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNGO IMAGING XS (MAGIC VIEW 300)

    MDR report key: 1504000 · Received September 9, 2009

    Report

    Report Number
    2240869-2009-00030
    Event Type
    Malfunction
    Date Received
    September 9, 2009
    Date of Event
    July 27, 2009
    Report Date
    August 4, 2009
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K082430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WILL BE TEMPORARILY CORRECTED WITH A SOFTWARE PATCH (ALREADY AVAILABLE). TO PERMANENTLY RESOLVE THIS ISSUE, NEW SOFTWARE, WILL BE RELEASED. THE NEW SOFTWARE WILL PERFORM A DETAILED VALIDATION OF EVERY SERIES THAT IS ARCHIVED. AFTER THE ZIP FILE IS CREATED THE NUMBER OF IMAGES, AND THE FILENAMES OF THE IMAGES WILL BE RECHECKED IN THE DATABASE AND IN THE ZIP FILE. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S ARCHIVED ZIP FILES DID NOT CONTAIN THE SAME NUMBER OF IMAGES AS LISTED IN THE (B)(4) AND ARCHIVE DATABASE. THERE IS A POSSIBILITY THAT NETWORK TRANSFER FAILURES MAY PREVENT A SERIES FROM BEING RECEIVED COMPLETELY. WHEN THIS ISSUE OCCURS, THE SERIES IS RECEIVED WITH AN ERROR STATUS. HOWEVER, AUTO ARCHIVING OF THE RECEIVED SERIES WILL STILL BE ATTEMPTED AND AN ADDITIONAL TASK WILL BE ADDED. THIS ISSUE WAS CAUSED BY THE RACE CONDITION BETWEEN NETWORK SERVICE AND ARCHIVING SERVICE NOT BEING ALIGNED DURING NETWORK ERRORS. A CUSTOMER SAFETY ADVISORY NOTICE WILL BE INITIATED TO INFORM ALL POTENTIALLY AFFECTED CUSTOMERS. THIS EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNGO IMAGING XS (MAGIC VIEW 300) SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ SIEMENS MEDICAL SOLUTIONS USA, INC. 10496279 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other