BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARESTREAM VUE PACS

    MDR report key: 3313757 · Received August 21, 2013

    Report

    Report Number
    1317307-2013-00014
    Event Type
    Other
    Date Received
    August 21, 2013
    Date of Event
    July 26, 2013
    Report Date
    August 21, 2013
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K060055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IDENTIFIED FIFTY FIVE (55) STUDIES THAT HAD NOT AUTOMATICALLY ARCHIVED TO THE GE PACS. FIFTY ONE (51) STUDIES WERE FOUND STILL ONLINE AND WERE SAVED ON THE GE PACKS. ONE (1) STUDY WAS FOUND TO BE DELETED BY THE USER BECAUSE THE USER BELIEVED IT WAS ON THE CARESTREAM BACKUP SERVER. THREE (3) STUDIES WERE FOUND TO BE NO LONGER AVAILABLE ON THE CARESTREAM BACKUP SERVER. CARESTREAM HEALTH, INC. BEGAN AN INVESTIGATION OF THE PROBLEM. THE INVESTIGATION INCLUDED REVIEW OF LOGS AND A VISIT TO THE SITE TO EVALUATE THE SYSTEM. THE SYSTEM AT THE SITE WAS CONFIGURED TO COPY INCOMING STUDIES TO THE GE PACS. THE THREE (3) LOST STUDIES, NOT DELETED BY THE USER, WERE PREVIOUSLY AVAILABLE ON THE CARESTREAM BACKUP SERVER AS OF (B)(6) 2012. CARESTREAM'S INVESTIGATION OF THE LOGS REVEALED THE STUDIES WERE SUCCESSFULLY STORED ON THE CARESTREAM BACKUP SERVER, BUT THERE WAS NO RECORD OF STUDIES BEING SENT TO THE GE PACS. CARESTREAM BELIEVES THAT THE INFO ROUTER JOB WAS NOT SUCCESSFUL, AND BECAUSE IT WAS NOT NOTICED BEFORE THE INFO ROUTER PURGES ITS JOBS AFTER 14 DAYS, THE CUSTOMER WAS UNAWARE THAT THE STUDIES WERE NOT ARCHIVED. THE SYSTEM WAS ALSO CONFIGURED TO ALLOW THE DELETION OF UN-ARCHIVED STUDIES, THEREFORE, WHEN THE SYSTEM REACHED THE HIGH WATER MARK, THE SYSTEM ALLOWED THE STUDIES TO BE DELETED. THE AFFECTED STUDIES WERE DATED (B)(6) 2012 (PRIOR YEAR MAMMOGRAPHY IMAGES). WHILE THE STUDY IMAGES WERE NO LONGER AVAILABLE, THE REPORTS AND DIAGNOSES FOR THESE STUDIES WERE STILL AVAILABLE ON THE (B)(4).

    Description of Event or Problem · 1

    ON (B)(4) 2013 CARESTREAM HEALTH RECEIVED A REPORT OF LOST IMAGES FROM FOUR (4) STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406519 CARESTREAM VUE PACS PACS LLZ CARESTREAM HEALTH, INC. VERSION 11.3

    Patients

    Seq Age Sex Outcome Treatment
    1 RIS| GE PACS