BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBIX

    MDR report key: 2129578 · Received June 6, 2011

    Report

    Report Number
    2129578
    Event Type
    Malfunction
    Date Received
    June 6, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 6, 2011
    Manufacturer
    CLINICAL COMPUTER SYSTEMS, INC.
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    STAFF ORIGINALLY HAD DIFFICULTY LOGGING ON TO THE OBIX SYSTEM. BY THE TIME CLINICAL ENGINEERING STAFF ARRIVED, THE LOGIN PROBLEM HAD RESOLVED BUT IT WAS NOTICED THAT THERE WAS NO AUDIO FOR THE ALARMS. FURTHER CONTACT WITH OBIX TECH SUPPORT SUGGESTED CHECKING THE MUTE FUNCTION ON THE COMPUTER. THE AUDIO WAS MUTED, AND AFTER CLICKING THE BUTTON, THE AUDIO WAS UNMUTED AND BEGAN WORKING PROPERLY. STAFF COMMENTED THAT THIS HAS BEEN AN ONGOING PROBLEM.THE AFFECTED ALARM AUDIO IS ONLY AT THE CENTRAL STATION (NURSES' DESK). IT DOES NOT AFFECT ALARMS AT THE BEDSIDE. VISUAL ALARMS ARE STILL FUNCTIONAL.THE MUTING FUNCTION IS ON THE WINDOWS XP OPERATING SYSTEM VOLUME CONTROL, SIMILAR TO WHAT YOU WOULD HAVE ON YOUR DESKTOP COMPUTER. THE CENTRAL STATION SOFTWARE IS RUNNING ON WINDOWS. TO ACCESS IT, YOU CLICK ON THE SPEAKER ICON IN THE SYSTEM TRAY, THEN THERE IS A CHECK BOX NEXT TO THE VOLUME SLIDER FOR MUTE. ====================== MANUFACTURER RESPONSE FOR PERINATAL DATA SYSTEM, OBIX (PER SITE REPORTER)======================APPARENTLY THEY ALREADY KNEW ABOUT THIS PROBLEM. THEY ARE WORKING ON A SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBIX PERINATAL DATA SYSTEM HGM CLINICAL COMPUTER SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES