BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 3221428 · Received July 2, 2013

    Report

    Report Number
    3023750-2013-00061
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WELCH ALLYN RECOMMENDED THAT THE CUSTOMER REPLACE THE BATTERY(S) ON UPS IN CLOSET. THE UPS IS AN OFF-THE-SHELF COMPUTER PERIPHERAL MADE BY ANOTHER MANUFACTURER AND SOLD BY WELCH ALLYN. WELCH ALLYN DOES NOT POSSESS TROUBLESHOOTING CAPABILITY BEYOND IDENTIFYING THESE SUBCOMPONENTS AS THE SOURCE OF THE FAILURE. METHOD: BMET CONFIRMED UPS FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR ACUITY SYSTEM SHUTDOWN DURING A MAINS POWER OUTAGE AND IS AT LOGIN PROMPT ASKING FOR A PASSWORD. CUSTOMER'S CLINICAL ENGINEERING TEAM DETERMINED THAT THEIR ACUITY SYSTEM WAS RUNNING BUT NO MONITORS WERE CONNECTING TO THE SYSTEM. FAULT TRACED TO THE UPS IN THE NETWORK CLOSET. THIS RESULTED IN A TEMPORARY INABILITY TO CENTRALLY MONITOR PATIENTS, HOWEVER BEDSIDE MONITORING WAS NOT AFFECTED. THERE WAS NO REPORT OF ANY PATIENT HARM AS A RESULT OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300577 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. POWERWARE 5115 UPS

    Patients

    Seq Age Sex Outcome Treatment
    1