BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER INFORMATION SYSTEMS

    MDR report key: 1305987 · Received January 16, 2009

    Report

    Report Number
    1305987
    Event Type
    Malfunction
    Date Received
    January 16, 2009
    Date of Event
    January 13, 2009
    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 HEMODYNAMIC MONITORING SYSTEM HAS A KNOWN SOFTWARE PROBLEM THAT CAUSES THE MACHINE TO RETURN TO PRE-EDITED MEASUREMENTS AFTER A FEW MINUTES. STAFF NEED TO MAKE NOTES ON PRINT OUTS AND DICTATE CORRECT RESULTS. 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.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *