BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNQUEST POWERPATH

    MDR report key: 3906855 · Received March 6, 2014

    Report

    Report Number
    2029302-2014-00002
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    SUNQUEST INFO SYSTEMS
    Product Code
    NVV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NINETY-ONE SITES HAVE BEEN NOTIFIED VIA PRODUCT SAFETY NOTICE (PSN) AND A CORRECTION WILL BE AVAILABLE FOR 10.0 AND 10.0.1 AND WILL BE CONTAINED IN ALL FUTURE VERSIONS. THERE ARE 0 SITES HAVE ALREADY BEEN CORRECTED. STEPS TO REPRODUCE: CREATE A NEW CASE. MANUALLY ENTER THE HIS ORDER NUMBER FOR AN IMPORTED ORDER. SAVE THE CASE.

    Description of Event or Problem · 1

    WHEN AN ORDER IS RECEIVED IN POWERPATH FROM A SENDING FACILITY, IF THE SENDING FACILITY SENDS THE SAME ORDER NUMBER FOR DIFFERENT PATIENTS, POWERPATH DOES NOT VERIFY THE ORDER NUMBER WHICH COULD RESULT IN A DUPLICATE ORDER NUMBER FROM THE SAME FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136989 SUNQUEST POWERPATH POWERPATH NVV SUNQUEST INFO SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1