BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFICEPACS

    MDR report key: 3446866 · Received September 10, 2013

    Report

    Report Number
    2183926-2013-00001
    Event Type
    Malfunction
    Date Received
    September 10, 2013
    Date of Event
    August 15, 2013
    Report Date
    September 9, 2013
    Manufacturer
    MERGE HEALTHCARE, INC
    Product Code
    LLZ
    PMA / PMN Number
    K033825
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OFFICEPACS MIGRATION TOOL THAT CAUSED THE MALFUNCTION IN THIS CASE, IS NOT A DEPLOYED FEATURE OF THE OFFICEPACS PRODUCT. THE TOOL IS USED BY THE INTERNAL PROFESSIONAL SERVICES TEAM AT MERGE TO PERFORM PACS MIGRATIONS. ONCE THE ISSUE WAS REPORTED, THE PROFESSIONAL SERVICES TEAM WAS ABLE TO EXAMINE LOG FILES ON THE DESTINATION DEVICE TO FIND THE MISMATCHED VALUES THAT DID NOT RECONCILE. THOSE STUDIES WERE MANUALLY DELETED THEN FROM THE SYSTEM AND RE-MIGRATED. (B)(4).

    Description of Event or Problem · 1

    AN ISSUE WAS DISCOVERED AT A CUSTOMER SITE (HIGHLANDS ORTHO). THE OFFICEPACS MIGRATION TOOL INCORRECTLY IDENTIFIED PT FOR PRIOR STUDIES DURING THE RECONCILIATION MIGRATION PROCESS. IMAGES WERE IDENTIFIED FOR A SPECIFIC PT IN ORTHOPACS POST-MIGRATION BUT THE IMAGES WERE DIFFERENT THAN THE ORIGINAL VISIT IN OFFICEPACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454418 OFFICEPACS MEDICAL IMAGE MANAGEMENT SYSTEM LLZ MERGE HEALTHCARE, INC OFFICEPACS 4.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA