BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARESTREAM VUE PACS

    MDR report key: 3530484 · Received November 14, 2013

    Report

    Report Number
    1317307-2013-00018
    Event Type
    Other
    Date Received
    November 14, 2013
    Date of Event
    October 16, 2013
    Report Date
    November 13, 2013
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K083673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IDENTIFIED SPECIFIC STUDIES THAT COULD NOT BE ACCESSED. CARESTREAM HEALTH, INC BEGAN AN INVESTIGATION OF THE ISSUE. THE INVESTIGATION INCLUDED REVIEW OF LOGS AND REMOTE EVAL OF THE SYSTEM. CARESTREAM'S INVESTIGATION OF THE DEVICE AND SERVER LOGS REVEALED THREE FACTORS THAT MAY HAVE CONTRIBUTED TO THE LOSS OF STUDIES AND STUDY IMAGES. PART OF THE INVESTIGATION WAS TO DETERMINE THE NUMBER OF AFFECTED STUDIES/IMAGES. AFFECTED STUDIES WERE STORED IN 2012, DURING AN INSTALLATION/UPGRADE OF THE PRIMARY PRODUCTION SERVER. DURING THE UPGRADE PERIOD THE BACKUP SERVER WAS ACTING AS THE PRODUCTION SYSTEM FOR THE SITE, RECEIVING STUDIES DIRECTLY FROM THE MODALITIES. THIS ACTING PRODUCTION SERVER WAS CONFIGURED TO COPY STUDIES TO THE PRIMARY SERVER, WHICH WOULD THEN ARCHIVE THE STUDIES. THE BACKUP SERVER WAS USING A "COPY RULE" ALONE IN THE INFO ROUTER SOFTWARE TO MOVE STUDIES TO THE PRIMARY SERVER WHERE THEY WERE THEN TO BE ARCHIVED IN LONG TERM STORAGE. WITHOUT AN ADDED "BACKUP RULE" THERE WAS NOT A 'STUDY_NEED_BACKUP' INDICATOR. THE WORKFLOW AT THE SITE WAS SET TO ALLOW DELETION OF UNARCHIVED IMAGES. WITH THAT WORKFLOW DISABLED, THE DELETION CRITERIA WOULD RESULT IN THE 'STUDY_NEED_BACKUP' INDICATOR. THE AFFECTED STUDIES/IMAGES WERE PRIOR EXAMS. WHILE THE STUDY IMAGES WERE NO LONGER AVAILABLE, THE REPORTS AND DIAGNOSES FOR THESE STUDIES WERE STILL AVAILABLE THROUGH THE PACS CLIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, CARESTREAM HEALTH RECEIVED A REPORT OF PRIOR IMAGES THAT COULD NOT BE ACCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592154 CARESTREAM VUE PACS PACS LLZ CARESTREAM HEALTH, INC. VERSION 11.3

    Patients

    Seq Age Sex Outcome Treatment
    1 CARESTREAM 10 LNG TRM SORAGE