BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELEPACS

    MDR report key: 2010466 · Received March 2, 2011

    Report

    Report Number
    9615916-2011-00001
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Report Date
    February 23, 2011
    Manufacturer
    INTELERAD MEDICAL SYSTEMS
    Product Code
    LLZ
    PMA / PMN Number
    K083520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION FROM THE REPORTING HEALTH FACILITY THAT ANY PT WAS AFFECTED ADVERSELY BY THIS MALFUNCTION. WHEN IT OCCURS, THE MALFUNCTION IS FAIRLY OBVIOUS. HOWEVER, WE ARE GOING TO REPAIR THE SOFTWARE AS A PREVENTIVE MEASURE AND DEPLOY IT TO AFFECTED CLIENTS.

    Description of Event or Problem · 1

    CLOSING THE PT TAB IN THE RADIOLOGIST'S REPORTING WORKLIST SOFTWARE, CLOSING THE REVIEW AND REPORTING SOFTWARE (INTELEVIEWER), OR A LOGIN SESSION TIME OUT IN THE INTELEVIEWER SOFTWARE, WHEN REPORTS ARE STILL OPEN IN THE DICTATION AND REPORTING TOOL, CAUSES INTELEVIEWER TO PROMPT THE USER TO "DISCARD", "CANCEL" OR "SAVE". PRESSING "SAVE" ACTUALLY SIGNS THE REPORT AND SENDS IT TO THE RADIOLOGY INFORMATION SYSTEM, WHERE IT MAY BE DISTRIBUTED OR READ BY REFERRING PHYSICIANS. THE "SAVE" UI INDICATION IS MISLEADING, IN THAT SOME RADIOLOGISTS MAY THINK THAT THE REPORT WILL BE TEMPORARILY SAVED, BUT INSTEAD WILL HAVE INADVERTENTLY SIGNED INCOMPLETE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELEPACS LLZ INTELERAD MEDICAL SYSTEMS INTELEVIEWER 421R13

    Patients

    Seq Age Sex Outcome Treatment
    1