BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING SYSTEM

    MDR report key: 1800538 · Received August 3, 2010

    Report

    Report Number
    3023750-2010-00139
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AN INSTALLED CENTRALIZED PATIENT MONITORING SYSTEM THAT UTILIZES A SUN MICROSYSTEMS CENTRAL PROCESSING UNIT (CPU) AND RELATED COMPUTER NETWORK PERIPHERALS. THE DEVICE RECEIVES, ANALYZES, AND DISPLAYS PATIENT VITAL SIGNS DATA FROM MULTIPLE BEDSIDE MULTI-PARAMETER PATIENT MONITORING DEVICES THROUGH EITHER WIRED OR WIRELESS CONNECTIONS. THE CUSTOMER REPORTED THAT HIS ACUITY CENTRAL MONITORING SYSTEM'S SECOND FLOOR ETHERNET SWITCH FAILED POST (POWER ON SELF TEST). THE SWITCH FAILED TO COMPLETE THE BOOT CYCLE. THIS RESULTED IN A LOSS OF CENTRAL MONITORING AND A LOSS OF COMMUNICATION TO OTHER ACUITY UNITS WITHIN THE SAME FACILITY. THE CUSTOMER REQUESTED ON-SITE SUPPORT WITH A REPLACEMENT SWITCH. A WELCH ALLYN FIELD ENGINEER WAS DISPATCHED AND HE WAS SUCCESSFUL IN UPGRADING THE CUSTOMER'S INFRASTRUCTURE THROUGH THE INSTALLATION OF A NEW ETHERNET SWITCH. THIS RESTORED CENTRALIZED MONITORING AND CORRECTED THE LOSS OF COMMUNICATIONS WITH ACUITY UNITS WITHIN THE FACILITY. THE SWITCH IS AN OFF-THE-SHELF PRODUCT. WELCH ALLYN DOES NOT POSSESS TROUBLESHOOTING CAPABILITY BEYOND IDENTIFYING THESE SUBCOMPONENTS AS THE SOURCE OF FAILURE. EVALUATION: EVALUATION PERFORMED VIA REMOTE TROUBLESHOOTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIS ACUITY CENTRAL MONITORING SYSTEM'S SECOND FLOOR ETHERNET SWITCH FAILED POST (POWER ON SELF TEST). THE SWITCH FAILED TO COMPLETE THE BOOT CYCLE. THIS RESULTED IN A LOSS OF CENTRAL MONITORING AND A LOSS OF COMMUNICATION TO OTHER ACUITY UNITS WITHIN THE SAME FACILITY. THE CUSTOMER DID NOT PROVIDE ANY PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING SYSTEM DSI WELCH ALLYN PROTOCOL, INC. ACUITY SW 6.31.01

    Patients

    Seq Age Sex Outcome Treatment
    1