BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 3273711 · Received July 24, 2013

    Report

    Report Number
    3023750-2013-00062
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K120774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BMET REPLACED THE FAILED FIBER SFP (SMALL FORM-FACTOR PLUGGABLE) MODULE IN THE (B)(4) NETWORK SWITCH AT THE SITE AND RESTORED WIRELESS NETWORK COMMUNICATIONS FOR THE ACUITY CENTRAL MONITORING SYSTEM. THE FAILED PART IS NOT BEING RETURNED TO WELCH ALLYN FOR EVALUATION. A (B)(4) NETWORK SWITCH AND ITS SUB-ASSEMBLIES ARE OFF-THE-SHELF COMPUTER PERIPHERALS MADE BY ANOTHER MANUFACTURER AND SOLD BY WELCH ALLYN. WELCH ALLYN DOES NOT POSSESS TROUBLESHOOTING CAPABILITY BEYOND IDENTIFYING THESE COMPONENTS AS THE SOURCE OF THE FAILURE. CONCLUSION: BMET TROUBLESHOT AND REPLACED (B)(4) FIBER SFP MODULE IN THE NETWORK SWITCH.

    Description of Event or Problem · 1

    CUSTOMER CALLED AND REPORTED THAT THEIR WIRELESS NETWORK FOR THE GUEST SERVICES WAS NOT WORKING. THEY COULD "SEE" THE NETWORK, BUT COULD NOT CONNECT. 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. THE CUSTOMER DID NOT PROVIDE ANY PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344380 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. CISCO 3560 SWITCH

    Patients

    Seq Age Sex Outcome Treatment
    1