BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBIX

    MDR report key: 5018003 · Received August 20, 2015

    Report

    Report Number
    5018003
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 25, 2015
    Manufacturer
    CLINICAL COMPUTER SYSTEMS, INC.
    Product Code
    HGM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE JUST DISCOVERED THAT A PATIENT HAS BEEN LISTED IN OBIX IN OPERATING ROOM 2 SINCE HER DELIVERY (WEEKS AGO). UNFORTUNATELY, NUMEROUS OTHER TRACINGS HAVE ALSO BEEN TRACED UNDER HER NAME AS HER NAME DID NOT DROP OUT OF THE OPERATING ROOM WHEN SHE WAS TRANSFERRED OUT TO ANOTHER LOCATION. WE HAVE NOW MANUALLY DISCHARGED HER FROM THE OBIX SYSTEM BUT THIS IS A MAJOR ISSUE THAT NEEDS TO BE ADDRESSED. WHEN DISCUSSING THIS, OTHER RNS AT THE DESK MENTIONED THAT THIS HAPPENS FREQUENTLY AND THAT THEY HAVE TO MOVE THE PATIENT BACK AND FORTH IN EPIC A FEW TIMES IN ORDER FOR THEM TO SHOW IN OBIX IN THE PROPER ROOM. NOTE: SOME ISSUE WITH THE OBIX SOFTWARE DOES NOT ALWAYS PROPERLY TRANSFER THE PATIENT AND DATA FROM OTHER PATIENTS CAN FLOW INTO THE RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550357 OBIX SYSTEM, MONITORING, PERINATAL HGM CLINICAL COMPUTER SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 THE OBIX SYSTEM INTERFACES TO THE PATIENT'S ELECTR