BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNQUEST POWERPATH

    MDR report key: 4070910 · Received August 29, 2014

    Report

    Report Number
    2029302-2014-00004
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    July 23, 2014
    Report Date
    August 22, 2014
    Manufacturer
    SUNQUEST INFO SYSTEMS
    Product Code
    NVV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NINETY FIVE SITES HAVE BEEN NOTIFIED VIA PRODUCT SAFETY NOTICE (PSN) AND A CORRECTION WILL BE AVAILABLE AS AN EMERGENCY PATCH FOR ALL AFFECTED VERSIONS. THERE ARE 0 SITES THAT HAVE ALREADY BEEN CORRECTED. NO INSTANCES OF PT HARM HAVE BEEN REPORTED AS A RESULT OF THIS ISSUE.

    Description of Event or Problem · 1

    THIS ISSUE WAS FOUND BY A CLIENT AT SITE. IN POWERPATH, ON RARE INSTANCES, TWO REPORTS MAY BE CREATED FOR THE SAME CASE AT THE TIME OF CASE SIGN-OUT. THESE REPORTS MAY CONTAIN INCOMPLETE DIAGNOSTIC INFO AND MAY BE SENT OVER THE RESULTS INTERFACE OR DISTRIBUTION SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528152 SUNQUEST POWERPATH POWERPATH NVV SUNQUEST INFO SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1