BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBIX

    MDR report key: 2451185 · Received January 30, 2012

    Report

    Report Number
    2451185
    Event Type
    Malfunction
    Date Received
    January 30, 2012
    Date of Event
    October 26, 2011
    Report Date
    December 16, 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

    AT 0700 THE HOSPITAL'S ACTIVE DIRECTORY SERVER LOST POWER. BY 0730 ALL BEDS WENT INTO A "HOLD" STATUS. ALL MONITORING HAD STOPPED. IT CAME BACK ON LINE AT 0930 WHEN THE ACTIVE DIRECTORY(A/D) SERVER CAME BACK ON LINE. OBIX RELIES ON LIGHT WEIGHT DIRECTORY PROTOCOL (LDAP) THROUGH ACTIVE DIRECTORY FOR OPERATION. THEY ONLY HAVE THE ABILITY TO PROGRAM ONE ACTIVE DIRECTORY SERVER.THE A/D SERVER THAT OBIX CHOSE AS AN AUTHENTICATION SOURCE WAS AT A REMOTE LOCATION. WE SINCE HAD THAT CHANGED TO A LOCAL SERVER. OBIX DOES NOT CURRENTLY HAVE THE CAPABILITY FOR LDAP TO SWITCH OVER TO AN ALTERNATE A/D SERVER IN THE EVENT OF A FAILURE. WE THINK THIS IS A DESIGN FLAW AS AN A/D LOSS BRINGS THE ENTIRE SYSTEM DOWN. THIS HAS HAPPENED AT LEAST TWICE IN THE PAST FEW MONTHS.THE OBIX SYSTEM FUNCTIONS AS THE PRIMARY PATIENT MONITORING SYSTEM FOR A 27 BED L&D UNIT FOR PATIENTS WITH HIGH RISK PREGNANCIES. IF THE SYSTEM FAILS, THERE IS NO WAY TO MONITOR ALL THE PATIENTS IN THE DEPARTMENT.======================MANUFACTURER RESPONSE FOR PERINATAL DATA SYSTEM, OBIX (PER SITE REPORTER).======================THEY INDICATE THE ISSUE WILL BE RESOLVED WITH THE NEXT VERSION OF SOFTWARE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *