BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNQUEST COPATHPLUS

    MDR report key: 3938587 · Received March 6, 2014

    Report

    Report Number
    2029302-2014-00001
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 10, 2014
    Report Date
    March 5, 2014
    Manufacturer
    SUNQUEST INFORMATION SYSTEM
    Product Code
    NVV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOURTEEN SITES HAVE BEEN NOTIFIED VIA PRODUCT SAFETY NOTICE (PSN) AND A CORRECTION WILL BE AVAILABLE IN COPATHPLUS VERSION 6.1.1 AND ABOVE. THERE ARE 0 SITES THAT HAVE ALREADY BEEN CORRECTED. STEPS TO REPRODUCE: LOGON AS SUNQUEST USER AND ACCESSION A SURGICAL SPECIMEN. NAVIGATE TO THE ELECTRONIC SIGNOUT FOR FINAL REPORT WINDOW FOR THE SPECIMEN. ENTER A LARGE AMOUNT OF TEXT IN THE FINAL DIAGNOSIS FIELD AND THEN CLICK ON SAVE/QUICK SIGN/OUT TO OPEN THE QUICK SIGN OUT REPORT. ADD SOME TEXT TO THE FIRST PARAGRAPH OF THE FINAL DIAGNOSIS TEXTFIELD AND CLICK CTRL-Z TO UNDO THESE ADDITIONS. CLICK ON EDIT SPECIMEN AND THEN ON OK TO SAVE CHANGES. ON RETURNING TO THE ELECTRONIC SIGNOUT FOR FINAL REPORT NOTICE THAT THE FIRST PARAGRAPH OF THE DIAGNOSIS IS MISSING. CLICK ON SAVE/QUICK SIGN/OUT TO OPEN THE QUICK SIGN OUT REPORT. CLICK CTR-O AND A SYSTEM ERROR WINDOW IS DISPLAYED. IF THE USER CLICK OK THEN THE COPATH APPLICATION CLOSES DOWN.

    Description of Event or Problem · 1

    WHILE USING THE COPATHPLUS QUICK SIGN-OUT REPORTS FEATURE, IF A USER PRESSES THE KEYBOARD SHORTCUT "CRL-Z" WHILE EDITING TEXT IN A DIAGNOSTIC TEXT FIELD, PORTIONS OF PREVIOUSLY SAVED TEXT MAY DISPPEAR UPON SAVING THE REPORT. WHILE USING THE COPATHPLUS QUICK SIGN-OUT REPORTS FEATURE, IF A USER PRESSES THE KEYPAD SHORTCUT "CTRL O" THE APPLICATION MAY CLOSE UNEXPECTEDLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134202 SUNQUEST COPATHPLUS COPATHPLUS NVV SUNQUEST INFORMATION SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1