BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 12595512 · Received October 7, 2021

    Report

    Report Number
    8030229-2021-01755
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    September 8, 2021
    Report Date
    March 28, 2023
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED INTERMITTENT COMM LOSS WITHIN THE FACILITY'S ER DEPARTMENT, AFFECTING MULTIPLE BEDSIDE MONITORS (BSMS) ON BOTH THE DEPARTMENT'S CENTRAL NURSE'S STATIONS (CNSS) AND REMOTE NETWORK STATIONS (RNSS). THIS HAD BEEN AN ONGOING ISSUE FOR SOME TIME. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: CUSTOMER STATED AN NK REP WAS ONSITE PREVIOUSLY FOR A NETWORK ISSUE. (TICKET 117926) ISSUE FOR PREVIOUS TICKET WAS INTERMITTENT COMM LOSS. NK REP WAS TOLD BY FACILITY NETWORK ENGINEER LEAD ISSUE WAS RESOLVED. THE DAY AFTER REPORTED ISSUE, AN NK TECHNICIAN WAS ONSITE FOR ANOTHER JOB AND FOUND ER COMMUNICATIONS TO BE STABLE. THE ISSUE WAS CHECKED UP ON THROUGHOUT THE DAY AND NO ISSUE WAS OBSERVED. FOLLOW UPS WITH CUSTOMER DID NOT RECEIVE A RESPONSE. THE ROOT CAUSE IS DETERMINED TO BE THE FACILITY'S NETWORK ENVIRONMENT. THE MOST LIKELY CAUSE OF COMM LOSS WAS DUE TO NETWORK SETTINGS/PERMISSIONS. FACILITY ENGINEERS RESOLVED THE ISSUE PREVIOUSLY. COMM LOSS IS AN ERROR MESSAGE NOTIFYING THE USER OF LOSS OF NETWORK COMMUNICATION BETWEEN THE MONITORING DEVICES AND THE CENTRAL NURSE'S STATION (CNS). POSSIBLE CAUSES OF A COMMUNICATION ERROR MESSAGE COULD BE WHEN THE NETWORK CABLE OR CONNECTOR IS DISCONNECTED OR FAULTY, IF THE WIRELESS ROUTER OR HUB IS FAULTY, IF THE SETTINGS OF THE BEDSIDE MONITOR ARE NOT THE SAME AS THE CNS OR IF THERE ARE DUPLICATE IP ADDRESSES BEING USED BY MORE THAN ONE BED. COMMUNICATION LOSS MAY ALSO OCCUR DUE TO ISSUES WITH THE CUSTOMER'S NETWORK ENVIRONMENT. NETWORK ACCESS POINT OVERLOAD MAY CAUSE AN UNSTABLE NETWORK CONNECTION AND MAY CAUSE DEVICES TO RANDOMLY DROP CONNECTION OR CAUSE THE HOST TABLE TO BECOME UNBALANCED. BECAUSE MOST NETWORK AND COMM LOSS ISSUES ARE DUE TO HOSPITAL NETWORK SETTINGS, CONNECTION ERRORS, OR OTHER USE ERRORS, ISSUES OF THIS TYPE ARE UNLIKELY TO BE CAUSED BY A DEVICE MALFUNCTION AND, THUS, DO NOT WARRANT A CORRECTIVE ACTION. DUE TO THE COMPLEX NATURE OF HOSPITAL NETWORK SYSTEMS, THESE ISSUES MAY RECUR DESPITE CORRECTLY FUNCTIONING EQUIPMENT.

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THERE WAS INTERMITTENT COMM LOSS WITHIN THE FACILITY'S ER DEPARTMENT. THEY STATED THAT MULTIPLE BEDSIDE MONITORS ARE CONTINUALLY GOING IN AND OUT OF COMMUNICATION LOSS ON BOTH THE DEPARTMENT'S CENTRAL NURSE'S STATIONS (CNSS) AND REMOTE NETWORK STATIONS (RNSS). THEY ALSO STATED THAT THIS HAS BEEN AN ONGOING ISSUE FOR SOME TIME. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED INTERMITTENT COMM LOSS WITHIN THE FACILITY'S ER DEPARTMENT, AFFECTING MULTIPLE BEDSIDE MONITORS (BSMS) ON BOTH THE DEPARTMENT'S CENTRAL NURSE'S STATIONS (CNSS) AND REMOTE NETWORK STATIONS (RNSS). THIS HAD BEEN AN ONGOING ISSUE FOR SOME TIME. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THERE WAS INTERMITTENT COMM LOSS WITHIN THE FACILITY'S ER DEPARTMENT. THEY STATED THAT MULTIPLE BEDSIDE MONITORS ARE CONTINUALLY GOING IN AND OUT OF COMMUNICATION LOSS ON BOTH THE DEPARTMENT'S CENTRAL NURSE'S STATIONS (CNSS) AND REMOTE NETWORK STATIONS (RNSS). THEY ALSO STATED THAT THIS HAS BEEN AN ONGOING ISSUE FOR SOME TIME. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485157 NI CENTRAL MONITOR STATION MHX NIHON KOHDEN CORPORATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown RNS-6803-7480 SN (B)(6).| RNS-6803-7480 SN (B)(6).