BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDISTAR

    MDR report key: 7842854 · Received September 4, 2018

    Report

    Report Number
    3011617252-2018-00001
    Event Type
    Malfunction
    Date Received
    September 4, 2018
    Date of Event
    August 6, 2018
    Report Date
    August 6, 2018
    Manufacturer
    HITACHI HEALTHCARE AMERICAS INFORMATICS
    Product Code
    LLZ
    PMA / PMN Number
    K083910
    Removal / Correction Number
    3011617252-08152018-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR FIRM INVESTIGATED THE CUSTOMER COMPLAINT OF INTERMIXED IMAGES AND WERE ABLE TO DETERMINE THAT THE PIECE OF SOFTWARE RESPONSIBLE FOR TRANSFERRING THE IMAGES FROM ONE SYSTEM TO ANOTHER (SSHFS VERSION 2.4) WAS INTERMIXING IMAGES UNDER SPECIFIC CIRCUMSTANCES. IMPLEMENTING CHECKSUM LOGIC TO THE APPLICATION'S LOGS REVEALED WHEN IN THE TRANSFER PROCESS IMAGES WERE INTERMIXED. THIS INDICATED THAT THE CULPRIT WAS A BUG IN THE TRANSFER SOFTWARE (SSHFS VERSION 2.4) AND NOT THE MODALITY, VIDISTAR PACS, NOR THE EHR SYSTEM. THE TRANSFER SOFTWARE (SSHFS) IS A THIRD-PARTY OPEN SOURCE SOFTWARE THAT WAS ORIGINALLY CHOSEN AND VALIDATED FOR THE INTERFACE BY VIDISTAR AND THE EHR SYSTEM. FURTHER INVESTIGATION SHOWED INSTABILITY OF THE MOUNT CREATED BY THE TRANSFER SOFTWARE (SSHFS VERSION 2.4) AT THE LEVELS OF TRAFFIC CREATED BY THE INTERFACE THUS OFFERING AN INCREASED LIKELIHOOD OF THE SPECIFIC CIRCUMSTANCES NECESSARY FOR THE BUG TO PRESENT.

    Description of Event or Problem · 1

    THE VIDISTAR PACS AND DICOM VIEWER SOFTWARE SYSTEM IS USED FOR THE TRANSFER, RECORDING, STORAGE, DISPLAY, AND POST-PROCESSING OF DIGITAL MEDICAL IMAGES, INCLUDING DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) DATA, MEASUREMENT QUANTIFICATION AND DATA MANIPULATION. VIDISTAR PACS IS SUPPORTING AN INTERFACE THAT PROVIDES THE IMAGES AND MEASUREMENTS TO A REMOTE EHR SYSTEM. SSHFS IS A SECURE FILE SYSTEM CLIENT USED TO MOUNT AND INTERACT WITH DIRECTORIES AND FILES LOCATED ON A REMOTE SERVER. DURING A STUDY TRANSFER TO THE REMOTE EHR SYSTEM, THE PATIENT IMAGES INCLUDED AN IMAGE FROM ANOTHER PATIENT'S STUDY. THE ADDITIONAL IMAGE WAS LABELED CORRECTLY, BUT WAS MISFILED. THE PROBLEM WAS CAUGHT BY THE TECHNICIAN BEFORE THE STUDY WAS INTERPRETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684793 VIDISTAR PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM LLZ HITACHI HEALTHCARE AMERICAS INFORMATICS VIDISTAR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other