BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SE HORIZON

    MDR report key: 897280 · Received August 8, 2007

    Report

    Report Number
    897280
    Event Type
    Malfunction
    Date Received
    August 8, 2007
    Date of Event
    March 14, 2007
    Report Date
    August 7, 2007
    Manufacturer
    MENNEN MEDICAL CORPORATION
    Product Code
    DXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    DURING A CARDIAC CATH PROCEDURE, THE MENNEN HEMODYNAMIC MONITOR FAILED AND THE MONITOR WOULD NOT SHOW ANY EKG TRACING OR HEART RATE. THIS EQUIPMENT HAS ALSO HAD SCREEN LOCK-UPS WITH ERROR MESSAGE "NO CONNECTION FROM CFE" DURING AT LEAST FOUR OTHER CATH LAB PROCEDURES EARLIER THIS YEAR. PATIENT WAS NOT HARMED; A PORTABLE MONITOR WAS IMMEDIATELY USED FOR PULSE AND EKG MONITORING. BIO-TECH HAS BEEN UNABLE TO DUPLICATE THE SCREEN LOCK-UPS, DISAPPEARANCE OF EKG TRACING, AND HEART RATE. THE MACHINE WOULD WORK IF THE CFE BUTTON WAS RESET. A FEW MONTHS AGO, A MENNEN FIELD SERVICE ENGINEER APPLIED A PATCH FOR SUN BLADE SYSTEMS THAT USE DUAL VIDEO CARDS. ONE IS BUILT ONTO THE MOTHER BOARD AND ONE IS ADDED ON TO THE VIDEO CARD. SINCE THE PATCH, WE HAVE CONTINUED TO HAVE THE SAME PROBLEMS INTERMITTENTLY ON FIVE PIECES OF THIS EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SE HORIZON HEMODYNAMIC SYSTEM, CATHERIZATION DXG MENNEN MEDICAL CORPORATION CONSOLE 9000 SE HORIZON *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR