BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 4176476 · Received July 24, 2014

    Report

    Report Number
    8022257-2014-00008
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETING THE INVESTIGATING, MCKESSON CONCLUDED THAT THE STUDY AVAILABLE IN (B)(6) HAD ONE IMAGE MISSING IN THE BAG, BUT THE IMAGE INDEX INDICATED THE IMAGE WAS PRESENT FOR THAT STUDY. 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. THIS DISCREPANCY CAUSED A FAILURE IN THE SEQUENCING PROCESS. 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 OCCUR: IMAGES MAY BE LOST OR UNAVAILABLE, LEADING THE 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 HAS DEVELOPED A SOFTWARE SOLUTION IN ORDER TO PREVENT THE RECURRENCE OF THIS ISSUE. MCKESSON IS WORKING WITH THE CUSTOMER TO IMPLEMENT THIS SOLUTION.

    Description of Event or Problem · 1

    MCKESSON RECEIVED A REQUEST FROM THE REPORTING FACILITY TO INVESTIGATE WHY SEQUENCING A STUDY THAT WAS NEWLY IMPORTED FROM AN MRI MODALITY IS TAKING LONGER THAN EXPECTED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433965 HORIZON MEDICAL IMAGING PICTURE ARCHIVING AND COMM. SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 11.6

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK