BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADSUITE

    MDR report key: 5437542 · Received February 15, 2016

    Report

    Report Number
    2183926-2015-00061
    Event Type
    Malfunction
    Date Received
    February 15, 2016
    Date of Event
    July 2, 2015
    Report Date
    February 15, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K053281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETROSPECTIVE REVIEW OF THIS CUSTOMER ISSUE, IT WAS DETERMINED TO BE REPORTABLE AS AN MDR. THE ROOT CAUSE WAS NOT RELATED TO RADSUITE BUT TO AN OUTSIDE SERVICE USED BY THE CUSTOMER.

    Description of Event or Problem · 1

    MERGE RADSUITE IS AN APPLICATION THAT 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 AND; TERTIARY CARE PHYSICIANS, MEDICAL TECHNOLOGISTS, AND INFORMATION TECHNOLOGY PROFESSIONALS CAN RECEIVE PATIENT RECORDS. ON (B)(6) 2015, THE CUSTOMER REPORTED ((B)(6)) THAT CASES BEING SENT FROM RADSUITE TO AN OFFSITE DESTINATION WAS SLOW. THIS WAS A THIRD PARTY PACS VENDOR THAT DOES OFFSITE READING FOR THE CUSTOMER. THE CUSTOMER SENDS FROM RADSUITE AT NIGHT FOR THEIR STROKE PATIENTS. THE SITE REQUIRES 3 MINUTE AVERAGE TRANSFER IN ORDER TO MEET 15 MINUTES COMPLETE TO FINAL TURNAROUND TIME FOR STROKE/PERFUSION PATIENTS. EXPORTING AT NIGHT COULD TAKE 20 - 40 MINUTES. THIS WAS DETERMINED TO BE A POTENTIAL SAFETY ISSUE IN THE EVENT THE INFORMATION IS NOT AVAILABLE FOR REVIEW, LEADING TO A DELAY IN TREATMENT FOR STROKE VICTIMS. THE ROOT CAUSE OF THIS ISSUE WAS NOT LINKED TO RADSUITE OR ANY OTHER MERGE PRODUCT. IT WAS TIED TO A 3RD PARTY VENDOR THAT ST. JOHN'S IS USING TO READ THEIR STUDIES AT NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94717 RADSUITE SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ MERGE HEALTHCARE 8.30.7.4

    Patients

    Seq Age Sex Outcome Treatment
    1