BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6801A

    MDR report key: 12339568 · Received August 18, 2021

    Report

    Report Number
    8030229-2021-01498
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 21, 2021
    Report Date
    March 30, 2023
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) STOPPED RECORDING VITALS FOR PATIENTS THAT WERE ON DEVICES CONNECTED VIA WIFI. THE CUSTOMER STATED THE THE CNS HAS A MIX OF DEVICES, BUT MOSLY GZ-130PA'S WITH ABOUT 5 BSM-1700'S. ACCORDING TO THE CUSTOMER, BED NAME PMTELE-56 GAVE COMM LOSS MESSAGE WHEN THE VITALS SIGNS DISAPPEARED. PATIENT ON DEVICES CONNECTED VIA NETWORK CABLE HAD NO ISSUES. THE CUSTOMER HAS UPLOADED THE LOGS. THERE WAS NO PATIENT INJURY 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.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) STOPPED RECORDING VITALS FOR DEVICES CONNECTED VIA WI-FI. THE CNS WAS MONITORING A MIX OF DEVICES, BUT MOSTLY GZ-TRANSMITTERS WITH ABOUT FIVE BSM-1700S. THE BED NAME PMTELE-56 GAVE A COMM LOSS MESSAGE WHEN THE VITAL SIGNS DISAPPEARED AT THE CNS. DEVICES CONNECTED VIA A NETWORK CABLE HAD NO ISSUES. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: THIS CNS WAS MONITORING PATIENTS FROM DIFFERENT FLOORS CONNECTED VIA WI-FI, THE OTHER HALF OF THE FLOOR WAS COVERED BY ANOTHER CNS; HOWEVER, THAT CNS HAD NO ISSUES WITH WI-FI ON THE SAME FLOOR. THE BIOMED HAD THEIR IT DEPARTMENT CHECK THE LOGS FOR WI-FI ISSUES FOR THE FLOORS WHERE VITAL SIGNS DISAPPEARED. NIHON KOHDEN (JAPAN) ANALYZED THE LOGS AND FOUND THAT THE MONITORS LOSS COMMUNICATION AT ONCE, AND THE MESSAGE "COMM LOSS" WAS TRIGGERED. IT WAS NOTED THAT THERE WAS NO COMMUNICATION FAILURE FOR THE CNS - THE DEVICE WAS CONNECTED TO THE NETWORK. THUS, THIS IS THE REASON THAT OCCURRED ON THE PATHWAY BETWEEN THE GZ TRANSMITTERS AND THE CNS. BASED ON THE REPORT THAT COMMUNICATION LOSS WAS OBSERVED FOR ONLY THE WI-FI CONNECTED DEVICES (GZ AND THE BSM 1700), THERE WAS LIKELY A WIRELESS NETWORK PROBLEM. SERVICE HISTORY FOR THIS FACILITY, REVIEWED FOR THE TIME FRAME OF 1 MONTH PRIOR TO AND ONE MONTH AFTER THE REPORTED EVENT FOR INCIDENTS RELATED TO WIRELESS CONNECTIVITY. NO OTHER INCIDENTS WERE FOUND. THE ANALYSIS FOUND NO DEVICE MALFUNCTION FOR THE CNS. WIRELESS DEVICES WERE NOT AVAILABLE FOR ANALYSIS. DUE TO THE NATURE OF THE EVENT WHERE THE COMMUNICATION LOSS OCCURRED ONLY FOR THE WIRELESS DEVICES, AND THAT NO OTHER REPORTS OF PATIENT CONNECTED DEVICE FAILURE, IT IS PRESUMED THAT THE CAUSE OF THE COMMUNICATION LOSS WAS RELATED TO THE WIRELESS NETWORK.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) STOPPED RECORDING VITALS FOR PATIENTS THAT WERE ON DEVICES CONNECTED VIA WIFI. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) STOPPED RECORDING VITALS FOR PATIENTS THAT WERE ON DEVICES CONNECTED VIA WIFI. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237664 CNS-6801A CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORPORATION CNS-6801A NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BEDSIDE MONITORS (BSM'S).| BEDSIDE MONITORS (BSMS).| GZ TRANSMITTERS.| GZ TRANSMITTERS.