BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 936804 · Received October 31, 2007

    Report

    Report Number
    3023750-2007-00239
    Event Type
    Malfunction
    Date Received
    October 31, 2007
    Date of Event
    January 23, 2007
    Report Date
    January 23, 2007
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K935846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE WAS PERFORMED REMOTELY VIA MODEM CONNECTION. THE METHOD OF EVALUATION WAS REMOTE INSPECTION OF DEVICE VIA MODEM CONNECTION. FAILURE DUE TO LONG USE. CONCLUSIONS: DEVICE FAILURE OCCURRED AND WAS DUE TO CONSUMPTION OF ALL AVAILABLE SPACE ON A COMPUTER HARD DISK DRIVE (DISK DRIVE FULL). MANUFACTURER'S EVALUATION SUMMARY: THE DEVICE (ACUITY) IS AN INSTALLED CENTRALIZED PATIENT MONITORING SYSTEM THAT UTILIZES A SUN MICROSYSTEMS CENTRAL PROCESSING UNIT (CPU). THE DEVICE RECEIVES, ANALYZES AND DISPLAYS PATIENT VITAL SIGNS DATA FROM MULTIPLE BEDSIDE MULTIFUNCTIONAL PATIENT MONITORING DEVICES THROUGH EITHER WIRED OR WIRELESS CONNECTIONS. THE CUSTOMER COMPLAINED THAT THE SYSTEM FAILED TO BOOT (COMMENCE PATIENT MONITORING). AN ADDITIONAL SYMPTOM OF A "GRINDING" NOISES COMING FROM THE CPU WAS ALSO REPORTED. SUBSEQUENTLY, THE SYSTEM WAS REPORTED TO BE RUNNING, BUT STOPPED AGAIN. ALTHOUGH CENTRALIZED MONITORING WAS LOST DURING THE TIME THAT THE SYSTEM WAS NOT RUNNING, PATIENT VITAL SIGNS MONITORING CONTINUED AT BEDSIDE WITH LOCAL BEDSIDE PATIENT MONITORS FOR ANY PATIENTS CONNECTED TO THE SYSTEM. THERE WERE NO PATIENTS HARMED IN ANY WAY BY THE EVENT. BY EVENT HERE OF FORM 3500A, WE MEAN THE LOSS OF CENTRALIZED MONITORING. INVESTIGATION CONCLUDED THAT THE REPORTED PROBLEMS WERE LIKELY CAUSED BY THE CPU'S HARD DISK DRIVE BECOMING TOO FULL. WHEN INSUFFICIENT DISK SPACE IS AVAILABLE TO THE COMPUTER OPERATING SYSTEM AND ACUITY APPLICATION SOFTWARE, THE SYSTEM MAY BECOME UNSTABLE, HALT OR FAIL TO SUCCESSFULLY RE-START (FAIL TO BOOT). LATER VERSIONS OF ACUITY SOFTWARE INCORPORATE NEW FEATURES TO REMOVE AGED FILES TO AVOID CONSUMING THE FINITE SPACE AVAILABLE ON HARD DISK DRIVES. THE DEVICE SOFTWARE PRESENTLY USED BY THE CUSTOMER, VERSION 3.15.03, WENT OBSOLETE IN MAY 1998. THE HARDWARE RUNNING THE ACUITY SOFTWARE, A SUN MICROSYSTEMS SPARC 5 CPU, IS ALSO OBSOLETE AND NO LONGER SUPPORTED BY ITS MANUFACTURER. THE DEVICE USER FACILITY HAS NOT YET ELECTED TO UPGRADE THEIR SYSTEM. THE NOISE REPORTED TO EMANATE FROM THE CPU IS INDICATIVE OF AGE-RELATED MECHANICAL WEAR ASSOCIATED WITH EITHER ONE OF THE FANS OR THE HARD DISK DRIVE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE CENTRAL MONITORING SYSTEM FAILED, INTERRUPTING CENTRALIZED PATIENT MONITORING. PATIENT VITAL SIGNS MONITORING CONTINUED AT THE BEDSIDE MONITORS. NOTE 1 FROM A1: HOSPITAL STAFF REPORTED THAT THERE WERE PATIENTS CONNECTED TO THE SYSTEM AT THE TIME, BUT DID NOT REPORT ANY PATIENT IDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY SW 3.15.03

    Patients

    Seq Age Sex Outcome Treatment
    1 YR