BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE ACCESS

    MDR report key: 2132435 · Received June 13, 2011

    Report

    Report Number
    2132435
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 13, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SIXTY FIVE DAYS AFTER THE BRAND NEW GENERAL ELECTRIC (GE) ENTERPRISE ACCESS PATIENT MONITORING SYSTEM NETWORK WENT DOWN AT 0200 HOURS IN THE MORNING. GE WAS CONTACTED AND THEIR TECHNICIAN DETERMINED THAT THE SYNCHMASTER WAS OUT. THE NETWORK WAS DOWN FOR APPROXIMATELY 5 HOURS. WHEN THE SYSTEM WAS SWITCHED OVER TO THE BACKUP SYNCHMASTER IT ALSO DID NOT WORK. THE PRIMARY DATA CABLE WAS THEN SWITCHED FROM THE PRIMARY SYNCHMASTER TO THE BACKUP SYNCHMASTER, AGAIN NO SYSTEM FUNCTIONALITY. THE HOSPITAL BIOMED PERSONNEL WERE ASKED TO REBOOT ALL 88 ACCESS POINTS AND THIS ALONG WITH THE SWITCH OVER TO THE BACKUP SYNCHMASTER PUT THE TELEMETRY SYSTEM NETWORK BACK ONLINE. WE BELIEVE THERE ARE TWO DESIGN ISSUES (1) IF THE PRIMARY SYNCHMASTER FAILS THERE SHOULD BE AN AUTOMATIC SWITCH TO THE BACK UP SYNCHMASTER WITHOUT NEEDING TO TURN THE PRIMARY "OFF" AND THE BACKUP "ON", AND (2)THERE SHOULD NOT BE ANY NEED TO "RE-BOOT". THIS FAILURE AFFECTED OVER 250 OF POTENTIALLY 300 PATIENTS AS THE ENTIRE TELEMETRY, WIRELESS MONITOR NETWORK WHEN IT WENT DOWN.MANUFACTURER RESPONSE FOR NETWORK, WIRELESS, PHYSIOLOGICAL MONITOR, ENTERPRISE ACCESS: REPRESENTATIVES OF GE SWITCHED OUT THE PRIMARY SYNCHMASTER FOR A NEW SYNCHMASTER. THEY ARE ALSO REVIEWING THE ENTIRE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE ACCESS NETWORK, WIRELESS, PHYSIOLOGICAL MONITORING DQK GE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *