BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2423666 · Received January 17, 2012

    Report

    Report Number
    3023750-2012-00004
    Event Type
    Malfunction
    Date Received
    January 17, 2012
    Date of Event
    October 7, 2011
    Report Date
    October 7, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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, AND DISPLAYS PT VITAL SIGNS DATA FROM MULTIPLE BEDSIDE MULTI-PARAMETER PT MONITORING DEVICES THROUGH EITHER WIRED OR WIRELESS CONNECTIONS. WELCH ALLYN ENGINEERING ANALYZED THE LOG FILES AND CONFIRMED THE PT MAPPED TO ANOTHER ACUITY SYSTEM WITHOUT USER INPUT. THE CLINICIAN PERFORMED AN END TELE ON THIS PT TO CORRECT THIS ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY HAD A PT CONNECTED TO ACUITY THAT WAS BEING MONITORED ON SOUTH2 AND THE PT KEPT DISAPPEARING FROM THIS SYSTEM AND RE-APPEARING ON THEIR ER SYSTEM. THE CLINICIANS WERE NOT ALERTED WHEN THE PT WARPED FROM ONE ACUITY STATION TO ANOTHER. THIS COULD LEAD TO A DELAY IN TREATMENT. BEDSIDE MONITORING WAS NOT AFFECTED. NO PT INJURY INVOLVED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY S/W 7.02.00

    Patients

    Seq Age Sex Outcome Treatment
    1