BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 1953952 · Received December 16, 2010

    Report

    Report Number
    3023750-2010-00171
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS PART OF 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 MULTIFUNCTIONAL PT MONITORING DEVICES THROUGH EITHER WIRED OR WIRELESS CONNECTIONS. THE CUSTOMER REPORTED THAT THEY HAD A (B)(4) MONITOR FOR AN ACUITY CENTRAL STATION THAT FAILED. THE VIDEO DISPLAY IS AN OFF-THE-SHELF COMPUTER PERIPHERAL MADE BY ANOTHER MFR AND SOLD BY (B)(4). (B)(4) SERVICE CONFIRMED MALFUNCTION. A MESSAGE "NO SIGNAL" IS DISPLAYED. THE UNIT WAS CHECKED AND SCRAPPED. THE (B)(4) DISPLAY IS AN OFF-THE-SHELF COMPUTER PERIPHERAL MADE BY ANOTHER MFR AND SOLD BY (B)(4). (B)(4) DOES NOT POSSESS TROUBLESHOOTING CAPABILITY BEYOND IDENTIFYING THESE SUBCOMPONENTS AS THE SOURCES OF FAILURE. THERE WAS NO PT HARM REPORTED ASSOCIATED WITH THIS FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEIR (B)(4) DISPLAY FOR THE ACUITY CENTRAL STATION HAD FAILED. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1