BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 1003751 · Received February 22, 2008

    Report

    Report Number
    3023750-2008-00060
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 25, 2008
    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 PAIR OF SUN MICROSYSTEMS CENTRAL PROCESSING UNITS (CPUS) 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 PROBLEM WAS CAUSED BY TWO EVENTS THAT OCCURRED ON THE SAME DAY. FIRST, ONE OF THE TWO CPUS (CENTRAL PROCESSING UNITS) FOR THE PT MONITORING SYSTEM FAILED. THIS DID NOT RESULT IN LOSS OF PT MONITORING BECAUSE THE SYSTEM INCLUDES A REDUNDANT CPU. LATER THE SAME DAY, THE REDUNDANT CPU EXPERIENCED A PROBLEM THAT CAUSED IT TO AUTOMATICALLY REBOOT (SHUT DOWN AND AUTOMATICALLY RESTART) RESULTING IN A LOSS OF CENTRAL PT MONITORING FOR A PERIOD OF ABOUT TEN MINS. THE FIRST PROBLEM WAS CAUSED BY CORRUPTION OF THE COMPUTER OPERATING SYSTEM THAT RESIDES ON THE CPU'S HARD DISK DRIVE. HOW THE OPERATING SYSTEM PROBLEM DEVELOPED COULD NOT BE IDENTIFIED. THE PROBLEM WAS CORRECTED BY RELOADING THE COMPUTER'S OPERATING SYSTEM AND THE ACUITY PT MONITORING SOFTWARE APPLICATION. NO HARDWARE FAULTS WERE FOUND. THE SECOND PROBLEM WAS CAUSED WHEN A SOFTWARE PROCESS FAILED TO PROPERLY RESPOND TO COMMUNICATION REQUESTS FROM A "WATCHDOG" PROCESS. WHEN THIS PROBLEM DID NOT RESOLVE WITHIN A CERTAIN AMOUNT OF TIME THE DEVICE ACTED TO CLEAR THE PROBLEM BY REBOOTING. THE AUTOMATIC REBOOT FEATURE IS DESIGNED TO RESOLVE PROBLEMS WITHOUT INTERVENTION BY THE DEVICE USER AND MINIMIZE SYSTEM DOWNTIME, WHICH IT SUCCESSFULLY DID NOT IN THIS CASE. SUBSEQUENT RELEASES OF ACUITY SOFTWARE HAVE REDUCED THE LIKELIHOOD OF THIS RARE TYPE OF EVENT OCCURRING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ONE OF THE TWO CPUS (CENTRAL PROCESSING UNITS) OF THEIR PT MONITORING SYSTEM FAILED. THIS DID NOT RESULT IN LOSS OF PT MONITORING BECAUSE THE SYSTEM INCLUDES A REDUNDANT CPU. LATER THE SAME DAY, THE REDUNDANT CPU EXPERIENCED A PROBLEM THAT CAUSED IT TO AUTOMATICALLY REBOOT (SHUT DOWN AND AUTOMATICALLY RESTART), RESULTING IN A LOSS OF CENTRAL PT MONITORING FOR A PERIOD OF ABOUT TEN MINUTES. DURING THE REBOOT PERIOD, PT MONITORING CONTINUED UNINTERRUPTED AT INDIVIDUAL BEDSIDE MONITORS. THERE WAS NO PT HARM ASSOCIATED WITH THIS REPORT. NOTE: THE REPORTER DID NOT PROVIDE AGE OR WEIGHT FOR THE PT IDENTIFIER SHOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1