BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 1974642 · Received December 29, 2010

    Report

    Report Number
    3023750-2010-00174
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AN INSTALLED CENTRALIZED PT MONITORING SYSTEM THAT UTILIZES A SUN MICROSYSTEMS CENTRAL PROCESSING UNIT (CPU) AND RELATED COMPUTER NETWORK PERIPHERALS. THE DEVICE RECEIVES, ANALYZES, ADN DISPLAYS PT VITAL SIGNS DATA FROM MULTIPLE BEDSIDE MULTI-PARAMETER PT MONITORING DEVICES THROUGH EITHER WIRED OR WIRELESS CONNECTIONS. WELCH ALLYN TECHNICAL SUPPORT ASSISTED THE CUSTOMER VIA THE TELEPHONE. JUST PRIOR TO DIALING INTO THE SYSTEM, THE CUSTOMER REPORTED THAT THEY HAD SWAPPED IN ANOTHER NETWORK CABLE TO CONNECT ACUITY TO THE WALL AND THE SYSTEM STARTED WORKING NORMALLY. ACCORDING TO THE CUSTOMER ,THERE WERE TWO BAD NETWORK CABLES. THESE CABLES WILL NOT BE RETURNED TO WELCH ALLYN AND WILL BE LOCALLY SCRAPPED. WITH NO PRODUCT BEING RETURNED, NO FURTHER FAILURE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HIS ACUITY CENTRAL PT MONITORING SYSTEM IS GETTING A CHECK NETWORK ERROR AND HE CANNOT SEE ANY OF HIS PTS. THIS RESULTED IN A TEMPORARY LOSS OF CENTRALIZED PT MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY SW 6.40.01

    Patients

    Seq Age Sex Outcome Treatment
    1