BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 4176707 · Received July 24, 2014

    Report

    Report Number
    8022257-2014-00009
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 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

    UPON COMPLETING THE INVESTIGATION, MCKESSON CONCLUDED THAT THERE WERE THREE STUDIES, EACH WITH ONE IMAGE MISSING FROM THE BAG BUT THE IMAGE INDEX INDICATED THE IMAGE WAS PRESENT FOR THAT STUDY. TWO STUDIES WERE REPAIRED, AS THE MISSING IMAGES EXISTED IN THE FILE REPLICATION SYSTEM. FOR THE THIRD STUDY THE MISSING IMAGE CANNOT BE RECOVERED. 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 DIRECTORY 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 OCCURS: 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. MCKESSON WILL PROVIDE A SOFTWARE SOLUTION TO THIS SITE IN ORDER TO PREVENT THE RECURRENCE OF THIS ISSUE.

    Description of Event or Problem · 1

    AFTER RECEIVING THE FIELD SAFETY NOTICE AS PART OF THE ONGOING VOLUNTARY RECALL 8022257-05-16-2014-003-C FROM MCKESSON, THE REPORTING SITE CONTACTED MCKESSON TO REQUEST A VERIFICATION OF THEIR DATA IN ORDER TO DETERMINE IF THE SITE WAS AFFECTED BY THE ISSUE DESCRIBED IN THE FIELD SAFETY NOTICE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435308 HORIZON MEDICAL IMAGING PICTURE ARCHIVING AND COMM. SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 11.9

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK