BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 4121853 · Received July 31, 2014

    Report

    Report Number
    3023750-2014-00020
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WELCH ALLYN FIELD SERVICE ENGINEER INVESTIGATED THE ISSUE AND DETERMINED THE ROOT CAUSE TO BE FAILED ETHERNET SWITCH. FIELD SERVICE RE-ROUTED THE ACUITY SYSTEM TO ANOTHER ETHERNET SWITCH. THE ETHERNET SWITCH WAS NOT PHYSICALLY ACCESSIBLE DUE TO IT BEING BEHIND OTHER EQUIPMENT THAT THE CUSTOMER DID NOT WANT TO MOVE AND AS RESULT, WELCH ALLYN FIELD SERVICE ENGINEER COULD NOT OBTAIN THE SERIAL NUMBER. ETHERNET 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR PATIENT MONITORS WERE INTERMITTENTLY DISCONNECTING FROM ACUITY CENTRAL STATION. WELCH ALLYN FIELD SERVICE ENGINEER EVALUATED THE ISSUE AND DETERMINED THAT ONE OF THE ETHERNET NETWORK SWITCHES FAILED. THERE WAS NO REPORT OF ANY PATIENT HARM AS A RESULT OF THE REPORTED EVENT. THE CUSTOMER DID NOT PROVIDE ANY PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449130 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1