BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER INFORMATION SYSTEM

    MDR report key: 1305983 · Received January 16, 2009

    Report

    Report Number
    1305983
    Event Type
    Malfunction
    Date Received
    January 16, 2009
    Date of Event
    December 31, 2008
    Report Date
    January 16, 2009
    Manufacturer
    WITT BIOMEDICAL CORPORATION
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS IS ONE OF THREE SYSTEMS HAVING THE SAME ISSUE.THE SYSTEM SAMPLES INVASIVE HEMODYNAMIC PRESSURES, UPON REVIEW OF A SAMPLED PRESSURE MEASUREMENT, THE TECHNOLOGIST EDITED THE MEASUREMENTS. AFTER A FEW MINUTES, THE SYSTEM CHANGED THE EDITED PRESSURES BACK TO THE PRE-EDITED MEASUREMENTS. THE SYSTEM DOESN'T PRINT OUT ACCURATE INFORMATION. STAFF HAS TO MAKE NOTES AND DICTATE THE ACTUAL RESULTS. COMPANY HAS STATED THAT IT IS A KNOWN SOFTWARE PROBLEM. PHILIPS UPDATED THE SOFTWARE IN SEPTEMBER TO: 1.1.1.1291 AND AGAIN IN JANUARY 2009 TO VERSION 1.2.1474 TO RESOLVE THE LATEST ISSUE.====================== MANUFACTURER RESPONSE FOR MONITORING SYSTEM, HEMODYNAMIC, XPER INFORMATION SYSTEM======================THIS SYSTEM PERFORMANCE ISSUE IS A POTENTIAL PATIENT SAFETY ISSUE. PHILIPS HAS ESCALATED OUR ISSUES THROUGH THEIR SYSTEM AND HAS AGREED TO AN ON SIGHT MEETING IN JANUARY TO DEVELOP A PLAN OF ACTION TO ADDRESS THESE PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPER INFORMATION SYSTEM MONITORING SYSTEM, HEMODYNAMIC MWI WITT BIOMEDICAL CORPORATION XPER *

    Patients

    Seq Age Sex Outcome Treatment
    1 *