BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNGO IMAGING

    MDR report key: 6584601 · Received May 23, 2017

    Report

    Report Number
    3002808157-2017-78797
    Event Type
    Malfunction
    Date Received
    May 23, 2017
    Date of Event
    April 25, 2017
    Report Date
    April 27, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    LLZ
    PMA / PMN Number
    K082430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO INJURIES ATTRIBUTED TO THE REPORTED EVENT. HOWEVER, CLINICALLY RELEVANT DATA LOSS OCCURRED . THIS REPORT WAS SUBMITTED MAY 23, 2017. CUSTOMER'S ADDRESS: (B)(6).

    Description of Event or Problem · 1

    A DATA LOSS IN THE SYNGO IMAGING APPLICATION OCCURRED FOR 62 OUT OF 601 IMAGES IN ONE SERIES ON (B)(6) 2017. NO DATA MIX-UP OCCURRED; NO PATIENT RESCAN WAS REQUIRED. DUE TO CHANGES ON THE POWER SUPPLY OF THE SYNGO IMAGING ENVIRONMENT PERFORMED BY THE CUSTOMER (B)(6) 2017, AN IMPROPER SHUTDOWN OF THE STORAGE TERM RAID AND THE SYNGO IMAGING APPLICATION OCCURRED. THIS RESULTED IN THE AFFECTED IMAGES BEING CREATED WITH 0 KB FILE SIZE IN THE SYNGO IMAGING'S SHORT TERM STORAGE PRIOR TO THEM BEING ARCHIVED IN THE LONG TERM ARCHIVE. THE AFFECTED SERIES WERE AVAILABLE IN THE SYNGO IMAGING VIEWER, HOWEVER, ONLY 539 IMAGES CAN BE DISPLAYED AND 62 IMAGES WERE CORRUPT. THESE CORRUPT IMAGES WERE FOUND DUE TO MAINTENANCE TASKS ON THE SYSTEM (B)(6) 2017. THE REPORTED INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364902 SYNGO IMAGING PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM. LLZ SIEMENS HEALTHCARE GMBH 10014063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other