BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE RADSUITE

    MDR report key: 6665951 · Received June 24, 2017

    Report

    Report Number
    2183926-2017-00130
    Event Type
    Malfunction
    Date Received
    June 24, 2017
    Date of Event
    May 25, 2017
    Report Date
    May 25, 2017
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K05328124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INVESTIGATION BY MERGE SUPPORT, BASED ON THE EXAMPLES PROVIDED BY THE CUSTOMER, IT APPEARS THAT THE STUDIES WERE ORDERED AND SENT IN WITHOUT A PATIENT LOCATION. THE PATIENT LOCATION WAS LATER UPDATED ON THE WORK LIST. HOWEVER, THE PATIENT LOCATION WASN'T UPDATED ON THE LONG TERM ARCHIVE BECAUSE THE STUDY HAD ALREADY BEEN ROUTED TO THE ARCHIVE PRIOR TO THE UPDATE TO THE PATIENT LOCATION. THE STUDIES ARE FOUND AND VIEWED FROM THE WORKLIST AND PATIENT LOCATION IS AN IMPORTANT FIELD TO THIS CUSTOMER. THE CUSTOMER'S WORKFLOW INCLUDES ADDING IN PATIENT LOCATION AFTER AN ORDER HAS ALREADY BEEN COMPLETED. MERGE TECHNICAL SUPPORT ASSISTED THE CUSTOMER BY ADDING IN A SHORT (1 MINUTE) DELAY BETWEEN CUSTOMER UPDATES TO THE WORKLIST AND THE RELATED STUDIES BEING SENT TO THE LONG TERM ARCHIVE. BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THE SHORT DELAY IN SENDING UPDATED REPORTS TO THE ARCHIVE HAS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    RADSUITE PROVIDES A MEANS TO DISTRIBUTE, DISPLAY, AND STORE DIAGNOSTIC-QUALITY MEDICAL IMAGES IN ELECTRONIC FORMAT. THE SYSTEM DISPLAYS TRADITIONAL 2D AND RECONSTRUCTED 3D RADIOLOGICAL IMAGES USING WEB ENABLED VIEWERS OVER BOTH LOCAL AND WIDE AREA NETWORKS. THE APPLICATION PROVIDES WORKFLOW INTEGRATION CAPABILITIES FOR HEALTH CARE ENTERPRISES, WHEREIN: RADIOLOGISTS CAN VIEW, ANNOTATE, AND TAG STUDIES AS DIAGNOSTICALLY READ. REFERRING PHYSICIANS CAN VIEW PATIENT IMAGES AND RADIOLOGISTS' ANNOTATIONS. TERTIARY CARE PHYSICIANS, MEDICAL TECHNOLOGISTS, AND INFORMATION TECHNOLOGY PROFESSIONALS CAN RECEIVE PATIENT RECORDS. ON 5/25/2017, MERGE HEALTHCARE TECHNICAL SUPPORT WAS NOTIFIED BY A RADSUITE CUSTOMER THAT PROCEDURES WERE NOT ABLE TO BE PERFORMED CAUSING A DELAY IN TREATMENT FOR 2 PATIENTS. PER THE CUSTOMER SITE, EMERGENCY DEPARTMENT STUDIES ARE TYPICALLY READ WITHIN 30 MINUTES HOWEVER, THERE WERE TWO STUDIES THAT WERE NOT READ UNTIL THE NEXT MORNING. WITH MERGE RADSUITE NOT FUNCTIONING AS EXPECTED, THERE IS A POTENTIAL FOR A DELAY IN DIAGNOSIS OR TREATMENT THAT MAY LEAD TO HARM. THERE WAS NO REPORTED HARM TO EITHER PATIENT A OR PATIENT B AS A RESULT OF THE DELAY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446451 MERGE RADSUITE PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM LLZ MERGE HEALTHCARE MERGE RADSUITE V8.30.7.9 P1

    Patients

    Seq Age Sex Outcome Treatment
    1