BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER

    MDR report key: 2580006 · Received May 11, 2012

    Report

    Report Number
    2580006
    Event Type
    Malfunction
    Date Received
    May 11, 2012
    Date of Event
    May 8, 2012
    Report Date
    May 11, 2012
    Manufacturer
    WITT BIOMEDICAL CORP.
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    THESE HAPPENED OVER THE COURSE OF A MONTH:1. WHILE DOCUMENTING MEDICATION INTO WITT LOG, THE MEDICATIONS DISAPPEARED AND HAD TO BE RE-ENTERED. THIS COULD CAUSE DOUBLE DOSING.2. HEMODYNAMIC MEASUREMENTS FREEZING ON SCREEN WHILE SNAPPING, THEN SCREEN INFO MOVES VERY QUICKLY ACROSS.3. UNABLE TO DOCUMENT MEDICATION INTO WITT.4. WHILE SWITCHING FROM SCREEN TO SCREEN IN THE WITT, TABS AT TOP OF SCREEN DISAPPEARED.5. HEMODYNAMIC NUMBERS CHANGING.6. HEMODYNAMIC RECORDING NUMBERS CHANGED.7. HEMODYNAMIC DATA CHANGING IN COMPUTER.8. HEMODYNAMIC WAVEFORMS FREEZE WHEN RECORDING, MAKING IT IMPOSSIBLE TO DO ANYTHING ELSE WITH COMPUTER.9. HEMODYNAMIC NUMBERS WERE CORRECTED BY TECHNOLOGIST, BUT COMPUTER CHANGED THEM BACK TO INCORRECT VALUES.10. EKG FROZE ON MONITOR, CAUSING A DELAY IN PROCEDURE. POTENTIAL RISK OF MISSING A HARMFUL ARRHYTHMIA.11. HOST PC FROZE POST DAILY MORNING REBOOT. HAD TO HARD BOOT, CAUSING DELAY IN BEGINNING PROCEDURE.12. WITT COMPUTER CHANGED NUMBERS. SOME OF THE WAVEFORMS WERE DELETEDWHILE PERFORMING CARDIAC OUTPUTS, THE WITT MONITOR FROZE. THEY CV HAD TO EXIT OUT OF THE PROCEDURE AND GET BACK WHILE THE CASE WAS GOING ON.13. WITT CHANGED LABEL OF HEMODYNAMICS. ANOTHER PRESSURE HAD TO BE TAKEN FOR ACCURACY.14. THE WITT MONITOR FROZE WHENEVER A HEMODYNAMIC WAVEFORM WAS SAMPLED HEMODYNAMIC WAVEFORMS FROZE WHILE SAMPLING.15. THERMODILUTION CARDIAC OUTPUT SCREEN FROZE HEMODYNAMIC DATA CORRECTED BY OPERATOR, THEN REVERTED BACK BY WITT (XIMS).16. WITT FROZE WHILE DOING TD CARDIAC OUTPUTS.17. HEMODYNAMIC WAVEFORMS FROZE WHILE SAMPLING.======================MANUFACTURER RESPONSE FOR HEMODYNAMIC MONITORING SYSTEM, XPER (PER SITE REPORTER).======================SLOW RESPONSE, SOME SOFTWARE CHANGES AND UPGRADES THAT HAVE NOT SEEMED TO HELP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *