BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2024022 · Received February 15, 2011

    Report

    Report Number
    3023750-2011-00012
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. WELCH ALLEN FACTORY SERVICE TESTED AND CONFIRMED THAT THE DISPLAY HAD FAILED. THE CAUSE OF THE PROBLEM IS OF UNKNOWN ORIGIN. THE DISPLAY MONITOR IS AN OFF-THE-SHELF COMPUTER PERIPHERAL MADE BY ANOTHER MANUFACTURER AND SOLD BY WELCH ALLYN. WELCH ALLYN DOES NOT POSSESS TROUBLE-SHOOTING CAPABILITY BEYOND IDENTIFYING THESE SUBCOMPONENTS AS THE SOURCE OF FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE OF THE DISPLAYS FOR (B)(4) ACUITY CENTRAL MONITORING SYSTEM FAILED. 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. ACUITY SW 7.10.01

    Patients

    Seq Age Sex Outcome Treatment
    1