BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNGO.PLAZA

    MDR report key: 3534166 · Received December 16, 2013

    Report

    Report Number
    2240869-2013-10269
    Event Type
    Other
    Date Received
    December 16, 2013
    Date of Event
    November 13, 2013
    Report Date
    November 13, 2013
    Manufacturer
    SIEMENS AG
    Product Code
    LLZ
    PMA / PMN Number
    K093612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOG FILES WERE REQUESTED BY OUR FACTORY EXPERTS FOR FURTHER INVESTIGATION. THE REQUESTED LOG FILES NO LONGER EXIST ON THE SYSTEM AND THE ROOT CAUSE HAS NOT YET BEEN DETERMINED. THE REPORTED ISSUE IS UNDER INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADD'L INFO HAS BEEN REC'D. (B)(6). THIS REPORT WAS SUBMITTED (B)(4) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 168 IMAGE FILES WITH 0 KB HAVE BEEN DETECTED ON THE SYNGO.PLAZA SYSTEM. THE SERIES CANNOT BE ARCHIVED. LAST REPORTED OCCURRENCE WAS DATED (B)(6) 2013. THE DATA WAS NOT ARCHIVED AND IMAGES ARE MISSING IN THE VIEWER AND PT LIST THUMBNAILS. NO INJURIES OR ADVERSE PT OUTCOME HAS BEEN ATTRIBUTED TO THIS ISSUE. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657526 SYNGO.PLAZA SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ SIEMENS AG 10863171 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other