BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON RADIOLOGY

    MDR report key: 4012737 · Received July 10, 2014

    Report

    Report Number
    8022257-2014-00007
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Removal / Correction Number
    8022257-05-16-2014-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON HAS IDENTIFIED AN ISSUE WHERE APPLICATION LOGIC LEADS TO DISCREPANCIES BETWEEN THE IMAGE INDEX AND THE CONTENT OF THE IMAGE FOLDER WHICH CAN CAUSE IMAGE LOSS. THE IMAGE FOLDER IS A FILE SYSTEM DIRECTOR WHERE IMAGES ARE STORED; IT ALSO CONTAINS THE IMAGE INDEX. THE IMAGE INDEX INDICATES TO THE APPLICATION A LIST OF IMAGE FILES TO EXPECT FOR USE WITHIN THE APPLICATION. IF THE IMAGE INDEX AND THE CONTENTS OF THE IMAGE FOLDER ARE NOT SYNCHRONIZED, THE FOLLOWING MAY OCCUR: IMAGES MAY BE LOST OR UNAVAILABLE, LEADING TO CLINICAL DECISIONS BEING MADE ON INCOMPLETE STUDIES AND/OR THE STUDY CANNOT BE ARCHIVED. IN THE EVENT OF A HARDWARE FAILURE, UNARCHIVED STUDIES MAY BE LOST LEADING TO PRIOR STUDIES NOT BEING AVAILABLE FOR COMPARISON. THE FOLLOWING FACTORS MAY CONTRIBUTE TO THE OCCURRENCE OF THE DISCREPANCY: NETWORK STABILITY ISSUES (FOR EXAMPLE: POOR PERFORMANCE, INSTABILITY AND COMMUNICATION ERRORS (DROPPED CONNECTIONS, PACKET LOSS)); DISK WRITE FAILURES (CANNOT WRITE TO DISK). THE PRODUCT MAY FAIL TO HANDLE THE OUTCOME OF SUCH FACTORS RESULTING IN THE DISCREPANCIES DESCRIBED ABOVE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SCRIPT EXECUTED AS PART OF A SCHEDULED STUDY MIGRATION PROCESS AT THE SITE, INDICATES THE EXISTENCE OF UN-ARCHIVED STUDIES WITH MISSING IMAGES. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405506 MCKESSON RADIOLOGY PICTURE ARCHIVING AND COMM. SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 12.0

    Patients

    Seq Age Sex Outcome Treatment
    1 UKN