BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADSUITE

    MDR report key: 4668279 · Received April 2, 2015

    Report

    Report Number
    2183926-2015-00001
    Event Type
    Malfunction
    Date Received
    April 2, 2015
    Date of Event
    February 25, 2015
    Report Date
    March 30, 2015
    Manufacturer
    MERGE HEALTHCARE INCORPORATED
    Product Code
    LLZ
    PMA / PMN Number
    K053281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RADSUITE IS A MEDICAL IMAGE VIEWING SOFTWARE APPLICATION THAT ALLOWS IMAGE DATA TO BE VIEWED FROM A FACILITY IMAGE CACHE (FIC) OR FROM A LONG TERM ARCHIVE (LTA). A CUSTOMER NOTICED THAT PATIENT A'S STUDY WAS STORED UNDER THE CORRECT PATIENT IN THE FIC BUT WAS STORED AS A DIFFERENT, PATIENT B, IN THE LTA. WHEN PATIENT A'S CURRENT STUDY WAS OPENED IN THE RADSUITE VIEWER ON THE LTA, PATIENT B'S STUDY WAS OPENED AS A PRIOR INSTEAD OF PATIENT A'S STUDY, AND WAS LABELED WITH PATIENT A'S INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220417 RADSUITE PACS MEDICAL IMAGE VIEWER LLZ MERGE HEALTHCARE INCORPORATED 5.35.4 HF 531

    Patients

    Seq Age Sex Outcome Treatment
    1