BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 3173499 · Received June 12, 2013

    Report

    Report Number
    3023750-2013-00056
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 18, 2013
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K120774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WELCH ALLYN FIELD SERVICE REPLACED THE DEFECTIVE FIBER SFP (SMALL FORM-FACTOR PLUGGABLE) MODULE IN THE (B)(4) NETWORK SWITCH AT THE CUSTOMER'S SITE AND RESTORED NETWORK COMMUNICATIONS BETWEEN THE PATIENT BEDSIDE MONITORS AND THE ACUITY CENTRAL MONITORING STATION. A (B)(4) NETWORK SWITCH AND ITS SUB-ASSEMBLIES ARE OFF-THE SHELF COMPUTER PERIPHERALS MADE BY ANOTHER MFR AND SOLD BY WELCH ALLYN. WELCH ALLYN DOES NOT POSSESS TROUBLESHOOTING CAPABILITY BEYOND IDENTIFYING THESE COMPONENTS AS THE SOURCE OF THE FAILURE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY COULD NOT SEE SEVEN PTS FROM FLOOR 5 ON THEIR ACUITY CENTRAL STATION. WELCH ALLYN TECHNICAL SUPPORT TROUBLESHOT THE ISSUE REMOTELY AND DETERMINED THAT ONE OF THE (B)(4) NETWORK SWITCHES HAD FAILED 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
    266369 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. CISCO 3560 SWITCH

    Patients

    Seq Age Sex Outcome Treatment
    1