BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE UNITY PACS

    MDR report key: 10192498 · Received June 24, 2020

    Report

    Report Number
    2183926-2020-00022
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    June 24, 2020
    Report Date
    June 24, 2020
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    UDI-DI
    00842000100461
    PMA / PMN Number
    K041935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    MERGE UNITY PACS IS A MEDICAL IMAGE AND INFORMATION MANAGEMENT SYSTEM THAT IS USED FOR VIEWING, SELECTION, PROCESSING, PRINTING, TELECOMMUNICATIONS, AND MEDIA INTERCHANGE OF MEDICAL IMAGES FROM A VARIETY OF DIAGNOSTIC IMAGING SYSTEMS. ON (B)(6) 2020, THE CUSTOMER REPORTED RECEIVING A "NO OBJECT FOUND" ERROR WHEN TRYING TO OPEN A REPORT FOR DICTATION TO IBM WATSON HEALTH IMAGING ON (B)(6) 2020. TROUBLESHOOTING FROM IBM WATSON HEALTH IMAGING SUPPORT FOUND THAT THE REPORT FOLDER WAS EMPTY, CAUSING THE "NO OBJECT FOUND" ERROR, AND THAT THERE WAS A REPORT SAVE EVENT PRESENT IN THE DEVICE AUDIT TRAIL. IBM WATSON HEALTH IMAGING SUPPORT REGENERATED THE REPORT TEMPLATE AND SAVED IT IN DICTATED (DID) STATUS. THE REPORT WAS SAVED WITH THE NEW TEMPLATE. THE REPORT WAS THEN READABLE. THIS HAS THE POTENTIAL TO DELAY PATIENT TREATMENT AND/OR DIAGNOSIS. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM AS A RESULT OF THIS ISSUE. REFERENCE COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653367 MERGE UNITY PACS PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, PRODUCT CODE: LLZ LLZ MERGE HEALTHCARE UNITY PACS 11.0.6 00842000100461

    Patients

    Seq Age Sex Outcome Treatment
    1