BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2436129 · Received January 11, 2012

    Report

    Report Number
    3023750-2012-00003
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 TECHNICAL SUPPORT REMOTELY ASSISTED THE BMET AND CONFIRMED THE FAILURE OF THE DISPLAY. THE BMET REPLACED THE DISPLAY AND LOCALLY DISPOSED OF THE FAILED DISPLAY. WITH NO PRODUCT BEING RETURNED TO WELCH ALLYN, NO FURTHER FAILURE INVESTIGATION WILL BE PERFORMED. EVAL METHOD: (REMOTE ASSISTANT).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A (B)(4) DISPLAY FAIL DURING USE (NO POWER). THIS RESULTED IN A TEMPORARY INABILITY TO MONITOR PTS CENTRALLY UNTIL THE CUSTOMER REPLACED THE DISPLAY. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENTS. THE CUSTOMER DID NOT PROVIDE ANY PT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. DISPLAY, 19", A/D

    Patients

    Seq Age Sex Outcome Treatment
    1