BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL STATION

    MDR report key: 1120363 · Received August 14, 2008

    Report

    Report Number
    3023750-2008-00198
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S EVALUATION SUMMARY: THE DEVICE (ACUITY) IS AN INSTALLED CENTRALIZED PATIENT MONITORING SYSTEM THAT UTILIZES A SUN MICROSYSTEMS CENTRAL PROCESSING UNIT (CPU) AND RELATED COMPUTER NETWORK PERIPHERALS INCLUDING ETHERNET SWITCHES. THE DEVICE RECEIVES, ANALYZES AND DISPLAYS PATIENT VITAL SIGNS DATA FROM MULTIPLE BEDSIDE MULTIFUNCTIONAL PATIENT MONITORING DEVICES THROUGH EITHER WIRED OR WIRELESS CONNECTIONS. TROUBLE-SHOOTING AT THE CUSTOMER'S LOCATION FOUND THAT NONE OF THE FOUR BEDSIDE MONITORING SITES WERE COMMUNICATING WITH ACUITY, CONSISTENT WITH A FAULT WITH THE ETHERNET SWITCH (OR ITS ASSOCIATED WIRING). THE CUSTOMER STATED THAT PRIOR TO REPORTING THE PROBLEM TO WELCH ALLYN, THEY HAD RE-SEATING CABLE CONNECTIONS AT THE ETHERNET SWITCH AND THAT ACTION HAD SOLVED THE DIFFICULTY IN THE RECENT PAST. THE ETHERNET SWITCH CONNECTS TELEMETRY ACCESS POINTS (APS) TO THE ACUITY CPU. THE ETHERNET SWITCH IS A COMMERCIAL, OFF-THE-SHELF PRODUCT MANUFACTURED BY MILAN TECHNOLOGY. IT WAS NOT RETUNED TO WELCH ALLYN FOR EVALUATION AND CONSEQUENTLY IT WAS NOT POSSIBLE TO CONFIRM FAILURE OF THE ETHERNET SWITCH. TREND ANALYSIS SHOWS PROBLEM REPORTS RELATING TO THIS ITEM ARE INFREQUENT. THERE WAS ONE SIMILAR REPORT IN 2008 (MDR #3023750-2008-00083) AND ONE IN 2007 (MDR # 3023750-2007-00278).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT BESIDE MONITORS WERE NOT COMMUNICATING WITH THE ACUITY. IN AN ATTEMPT TO RESOLVE THE PROBLEM THE CUSTOMER ELECTED TO INITIATE A REBOOT OF ACUITY. THE SYSTEM RESPONDED TO THIS COMMAND AS EXPECTED AND PATIENT MONITORING WAS RESTORED AFTER THE 4-5 MINUTE REBOOT PERIOD. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED PRODUCT PROBLEM. THE REPORTER DID NOT PROVIDE OTHER INFORMATION FOR THE PATIENT IDENTIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL STATION DSI WELCH ALLYN PROTOCOL, INC. ACUITY 6.40.01 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1