BEUDAMED
    FDA Adverse Event Summary report: N

    MERGE CADSTREAM

    MDR report key: 5927929 · Received September 5, 2016

    Report

    Report Number
    2183926-2016-00714
    Date Received
    September 5, 2016
    Date of Event
    August 4, 2016
    Report Date
    August 4, 2016
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K09294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE, PER INFORMATION OBTAINED BY MERGE HEALTHCARE, INDICATES THAT THERE WAS A USER ERROR THAT ORIGINATED ON THE MRI MODALITY. THE CUSTOMER CONTACTED MERGE SUPPORT FOR ASSISTANCE IN TRYING TO MINIMIZE THE ISSUE WITH THE INCORRECT LATERALITY INFORMATION DUE TO ORIENTATION OF THE PATIENT AND SETTINGS AT THE MODALITY. ADDITIONALLY, THE USER MANUAL AND REFERENCE GUIDE DESCRIBE THE LIMITATIONS OF CADSTREAM WHICH CAUTION DIAGNOSTIC OR OTHER PATIENT MANAGEMENT DECISIONS SHOULD NOT BE BASED SOLELY ON THE RESULTS OF CADSTREAM.

    Description of Event or Problem · 1

    MERGE CADSTREAM IS INTENDED TO BE USED FOR VIEWING, ANALYZING, REPORTING, COMMUNICATING AND STORING DIGITAL IMAGES DERIVED FROM AN MR IMAGE MODALITY. CADSTREAM FUNCTIONALITY INCLUDES RECORDING, ANNOTATING, CALCULATIONS, PATIENT MEDICATION/INTERACTION INFORMATION, MONITORING AND TOOLS TO MODIFY/ENHANCE IMAGE AND DEMOGRAPHIC INFORMATION. ON (B)(6) 2016, A CUSTOMER REPORTED TO MERGE HEALTHCARE THAT IMAGES WERE TAKEN OF A PATIENT WITH THE INCORRECT LINEALITY AT THE MODALITY AND WERE APPEARING THAT WAY IN MERGE CADSTREAM. DUE TO A USER ERROR, IMAGES ACQUIRED DURING MRI SCANNING WERE LABELED WITH THE INCORRECT ORIENTATION ON THE MR SCANNER. PER THE CUSTOMER'S REQUEST, MANUAL PROCESSING OF STUDY BY MERGE SUPPORT RESULTED IN ALL IMAGES REFLECTING THE INCORRECT LATERALITY AND ANTERIOR/POSTERIOR POSITIONING EMBEDDED IN EVERY IMAGE. STUDY RESULTS HAVE THE POTENTIAL TO BECOME PART OF THE PATIENTS PERMANENT RECORD AND HAVE THE POTENTIAL TO IMPACT PATIENT TREATMENT WHICH COULD LEAD TO DEATH OR SERIOUS INJURY. THERE IS NO INDICATION THAT THIS ISSUE AS REPORTED BY THE CUSTOMER HAS RESULTED IN ANY HARM TO A PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579329 MERGE CADSTREAM IMAGING PROCESSING SYSTEM LLZ MERGE HEALTHCARE MERGE CADSTREAM V6.0.1.933

    Patients

    Seq Age Sex Outcome Treatment
    1