BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL STATION

    MDR report key: 1122225 · Received August 15, 2008

    Report

    Report Number
    3023750-2008-00199
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K070204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    HARD DISK DRIVE FAILED. MFR'S EVALUATION SUMMARY: THE DEVICE IS AN INSTALLED CENTRALIZED PATIENT MONITORING SYSTEM THAT UTILIZES A SUN MICRO-SYSTEMS COMPUTER NETWORK PERIPHERALS. THE DEVICE RECEIVES, ANALYZES AND DISPLAYS PATIENT VITAL SIGNS DATA FROM MULTIPLE BEDSIDE MULTI-FUNCTIONAL PATIENT MONITORING DEVICES THROUGH EITHER WIRED OR WIRELESS CONNECTIONS. EVALUATION OF THE RETURNED DEVICE CONFIRMED THE MALFUNCTION. INVESTIGATION ISOLATED THE PROBLEM TO A FAILED SEAGATE HARD DISK DRIVE. BASED ON THE DEVICE'S INSTALLATION DATE AND THE DATE OF THE MALFUNCTION, THE DEVICE'S ESTIMATED OPERATING TIME PRIOR TO FAILURE WAS 32,000 HOURS OF USE. GIVEN THE FOREGOING, RELIABILITY ANALYSIS CONCLUDED THAT THE DISK DRIVE FAILURE WAS NOT AN UNUSUAL OCCURRENCE AND IS CONSISTENT WITH WHAT IS USUAL AND CUSTOMARY FOR COMPONENTS OF THIS KIND. THE FAILED DISK DRIVE WAS REPLACED TO CORRECT THE PROBLEM AND THE REPAIRED DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE DEVICE DISPLAYED A "PROGRAM TERMINATED" MESSAGE ON THE SCREEN AND AN "OK" PROMPT. THE CUSTOMER'S ATTEMPTS TO REBOOT (RESTART) THE DEVICE TO RESTORE OPERATION WERE UNSUCCESSFUL. THERE WERE NO PATIENTS CONNECTED TO THE DEVICE AT THE TIME OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL STATION DSI WELCH ALLYN PROTOCOL, INC. ACUITY SW 7.01.00 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1