BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 843945 · Received February 28, 2007

    Report

    Report Number
    3023750-2007-00022
    Event Type
    Malfunction
    Date Received
    February 28, 2007
    Date of Event
    January 25, 2007
    Report Date
    January 29, 2007
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MHX
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S EVAL SUMMARY: THE DEVICE IS AN INSTALLED CENTRALIZED PT MONITORING SYSTEM THAT UTILIZES A SUNBLADE 1500 CENTRAL PROCESSING UNIT (CPU). THIS SYSTEM HAS TWO CPUS IN A HIGH AVAILABILITY PAIR (HA PAIR) CONFIGURATION. AN HA PAIR CONFIGURATION ENSURES A HIGHER PERCENTAGE OF UPTIME WITHOUT LOSS OF CENTRALIZED MONITORING BECAUSE EACH CPU IN THE PAIR IS CAPABLE OF HANDLING THE ENTIRE PT LOAD IF THE OTHER SHOULD GO DOWN. THE CUSTOMER BIOMED REPORTED THAT HE BROUGHT SYSTEM CMR-1 HA, IN A PLANNED SHUTDOWN TO MOVE CABLES TO REDUCE CABLE LENGTHS. WHEN THE HA UNIT WENT DOWN, THE CMR-1 UNIT, REBOOTED SOON AFTERWARDS IN AN UNPLANNED REBOOT, RESULTING IN A LOSS OF CENTRALIZED MONITORING FOR APPROX 22 MINUTES. THERE WERE 33 PTS BEING MONITORED ON THIS HA PAIR AT THE TIME THAT CENTRALIZED MONITORING WAS LOST. EVEN THOUGH CENTRALIZED MONITORING WAS LOST DURING THE TIME THAT THE SYSTEM WAS DOWN, PT VITAL SIGNS MONITORING CONTINUED AT BEDSIDE WITH THE LOCAL BEDSIDE PT MONITORS. THERE WERE NO PTS HARMED IN ANY WAY BY THE EVENT. BY EVENT HERE AND IN THE CODES OF FORM 3500, WE MEAN THE LOSS OF CENTRALIZED MONITORING. THE CUSTOMER CALLED WELCH ALLYN TECH SUPPORT ON 01/29/07, FOUR DAYS AFTER THE EVENT, TO REPORT THE EVENT. TECH SUPPORT DOWNLOADED THE DEVICE LOGS, WHICH ENABLED THEM TO CONFIRM THE REPORTED EVENT. WELCH ALLYN ACUITY SOFTWARE ENGINEERING FOUND THAT THE UNPLANNED REBOOT OF THE CMR-1 SYSTEM WAS CAUSED PARTLY BY THE WAY THE BIOMED BROUGHT DOWN CMR-1-HA AND PARTLY BY THE FACT THAT USERS ON CMR-1 WERE ACCESSING INFO FROM CMR-1-HA AT THE TIME THAT IT WENT DOWN. THE BIOMED FIRST INSTRUCTED THE ACUITY APPLICATION TO QUIT ON CMR-1-HA. THAT PROMPTED THE SYSTEM TO BEGIN SWITCHING PTS FROM CMR-1-HA TO CMR-1 AS IT SHUT DOWN THE ACUITY APPLICATION AS EXPECTED. DURING THE SHORT TIME THAT ACUITY WAS SWITCHING PTS TO CMR-1, THE BIOMED INSTRUCTED THE CMR-1-HA CPU TO HALT, WHICH IS ANALOGOUS TO PRESSING CONTROL-ALT-DELETE TWICE ON A WINDOWS CPU. IT TERMINATES THE COMPUTER'S ABILITY TO RESPOND. MEANWHILE, A USER ON CMR-1 WAS INSTRUCTING THAT SYSTEM TO ACCESS PT TREND DATA STILL CONTROLLED BY CMR-1-HA THAT HAD NOT YET BEEN TRANSFERRED OVER TO CMR-1 BEFORE THE HALT COMMAND ON CMR-1-HA. CMR-1 KEPT ISSUING COMMANDS TO RESTART THE TREND DATA APPLICATION AND TO RE-INITIATE THE LINKS TO CMR-1-HA, WHICH COULD NOT RESPOND BECAUSE OF THE HALT COMMAND. ACUITY IS DESIGNED TO RESTART IN SITUATIONS LIKE THIS, WHICH IT DID ON CMR-1, RESULTING IN THE DOWN TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CMR-1-HA WAS BROUGHT DOWN TO MOVE CABLES AND REDUCE CABLE LENGTHS. AT THIS POINT, THE PRIMARY SYSTEM CAME DOWN AS WELL. CENTRALIZED MONITORING WAS LOST FOR 22 MINUTES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *