BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYBGO PLAZA

    MDR report key: 2598713 · Received May 18, 2012

    Report

    Report Number
    2240869-2012-00039
    Event Type
    Malfunction
    Date Received
    May 18, 2012
    Date of Event
    April 19, 2012
    Report Date
    April 19, 2012
    Manufacturer
    SIEMENS , AG.
    Product Code
    IZH
    PMA / PMN Number
    K042095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW UI (UPDATE INSTRUCTION) WILL BE DISTRIBUTED TO ALL AFFECTED CUSTOMERS. WITH THIS UI, ALL AFFECTED DATA WILL BE FOUND AND DELETE PROTECTION WILL BE SET ON THE DATA TO PREVENT DATA LOSS. FOR ALL NEW INSTALLATIONS, THIS UI WILL BE INSTALLED AS WELL. WITH THE NEW SOFTWARE, VA20D, THE DATA LOSS IS PREVENTED IN THE SOFTWARE. ADD'L MEASURES WILL BE TAKEN AS WELL; A TOOL (SET DELETE PROTECTION TOOL) WILL BE RELEASED TO FIND AFFECTED DATA AND SET THE DELETE PROTECTION FOR SUCH DATA. THIS TOOL SHALL BE ADDED TO THE MAINTENANCE TASK AT THE SITES AND HAS TO RUN ONCE A DAY. THIS WILL BE RELEASED AS A SEPARATE UPDATE INSTRUCTION (UI SY129/12/S). AS AN IMMEDIATE MEASURE TO PREVENT DATA LOSS, UPDATE OF STORED PROCEDURES IN DATABASE WILL BE DONE TO "DELETE PROTECT" AFFECTED DATA AND DOUBLE-CHECK BEFORE CHANGE OF "ARCHIVE STATUS" (IN SOFTWARE VD20D); FOR ALL NEW INSTALLATIONS, THE UI SY129/12/S HAS TO BE INSTALLED IN ADDITION TO THE NEW VD20D SOFTWARE; ARCHIVE NOW TOOL WILL BE ENHANCED TO ARCHIVE THE AFFECTED SERIES. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE SYNGO PLAZA ARCHIVE ONLINE STS (SHORT-TERM STORAGE SYSTEM) THERE ARE STUDY ENTRIES WITH ARCHIVED SYMBOL, BUT NO ENTRY IN THE ARCHIVE DB (NO LINK TO THE FILE IN THE LTS - LONG TERM STORAGE). IF THE STUDY IS DELETED IN THE ONLINE STS, THE PICTURES ARE LOST. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT. THIS EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYBGO PLAZA SYSTEM, IMAGE PROCESSING, RADIOLOGICAL IZH SIEMENS , AG. 10592457 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other