BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2844951 · Received October 24, 2012

    Report

    Report Number
    3023750-2012-00082
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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 ARUBA MASTER CONTROLLER CONTAINED 2 POWER SUPPLIES, ONE OF THE POWER SUPPLIES, ONE OF THE POWER SUPPLIES WAS FAULTY. AS A RESULT, THE 4 ACCESS POINTS IN THE RED ZONE WERE OUT OF ACTION. THERE WERE 6-7 BEDSIDE MONITORS CONNECTED THAT DROPPED OUT. AS A RESULT THE MASTER CONTROLLER WAS REPLACED UNDER WARRANTY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEIR ACCESS POINT(S) WERE NOT WORKING. SUSPECTED FAULTY CONTROLLER POWER SUPPLY FOR THE POWER OVER ETHERNET (POE) CONNECTIONS. THIS RESULTED IN A TEMPORARY INABILITY TO CENTRALLY MONITOR PATIENTS, HOWEVER BEDSIDE MONITORING WAS NOT AFFECTED. THERE WAS NO REPORT OF ANY PATIENT HARM AS A RESULT OF THE REPORTED EVENT. THE CUSTOMER DID NOT PROVIDE ANY PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ARUBA 800-16

    Patients

    Seq Age Sex Outcome Treatment
    1