BEUDAMED
    FDA Adverse Event Summary report: N

    ICENTRAL

    MDR report key: 1200463 · Received October 6, 2008

    Report

    Report Number
    9610105-2008-00022
    Date Received
    October 6, 2008
    Date of Event
    June 29, 2008
    Report Date
    October 6, 2008
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    MSX
    PMA / PMN Number
    K052972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NT
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL UNITY NETWORK ARRYTHMIA ALARMS (CRISIS AND/OR WARNING LEVEL) ARE NOT GENERATED ON ICENTRAL. BEDSIDE ALARMS ARE GENERATED. IT WAS ALSO REPORTED THAT THE "PATIENT DISCONNECTED" MESSAGE IS DISPLAYED IN THE PATIENT WINDOW FOR ALL ADMITTED PATIENTS ON ICENTRAL. NO PATIENT INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICENTRAL NETWORKING PRODUCTS MSX GE HEALTHCARE FINLAND OY L-NET05 5.0

    Patients

    Seq Age Sex Outcome Treatment
    1