CNS-6801A
Report
- Report Number
- 8030229-2021-00337
- Event Type
- Malfunction
- Date Received
- June 14, 2021
- Date of Event
- May 16, 2021
- Report Date
- February 28, 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
- VA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS GETTING COMM LOSS FOR ALL DEVICES, INCLUDING BEDSIDE MONITORS (BSMS) AND GZ TRANSMITTERS, HOSPITAL-WIDE. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: NIHON KOHDEN TECHNICAL SUPPORT (NK TS) NOTED DURING THE INITIAL REPORT OF THE ISSUE THAT THE SERVER OS LICENSE HAD EXPIRED. THE CUSTOMER EXTENDED THE TRIAL FOR 180 DAYS, AND THE SERVER WAS THEN ABLE TO POWER ON. THERE WAS NO COMMUNICATION LOSS AFTER THE SERVER BOOTUP. NK TS REMOTED INTO THE SERVER AND OBSERVED THAT THE MIRTH DATABASE WAS HUNG UP. NK TS REQUESTED ASSISTANCE FROM CLINICAL (CITS), WHO IDENTIFIED THE CAUSE OF THE MIRTH DATABASE ISSUE AND CORRECTED THE PROBLEM. THE ROOT CAUSE IS DETERMINED TO BE THE RESULT OF THE SERVER OS LICENSE EXPIRATION (USE ERROR). REVIEW OF THE SERIAL NUMBER HISTORY FINDS NO RECURRENCE OF THE REPORTED ISSUE. THE POSSIBLE CAUSES OF A NETWORK MALFUNCTION COULD BE HOST 1000 SERVER/H1K SERVER SHUTDOWN, IMPROPER DATA STORAGE, INCORRECT DEFAULT GATEWAY, LICENSING IS DISPROPORTIONATE: THE NUMBER OF MONITORS VS LICENSES FOR THEIR USE, AND A HUNG SERVER.
DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) WAS GETTING COMM LOSS FOR ALL DEVICES, INCLUDING BEDSIDE MONITORS (BSMS) AND GZ TRANSMITTERS, HOSPITAL-WIDE. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: NIHON KOHDEN TECHNICAL SUPPORT (NK TS) NOTED DURING THE INITIAL REPORT OF THE ISSUE THAT THE SERVER OS LICENSE HAD EXPIRED. THE CUSTOMER EXTENDED THE TRIAL FOR 180 DAYS, AND THE SERVER WAS THEN ABLE TO POWER ON. THERE WAS NO COMMUNICATION LOSS AFTER THE SERVER BOOTUP. NK TS REMOTED INTO THE SERVER AND OBSERVED THAT THE MIRTH DATABASE WAS HUNG UP. NK TS REQUESTED ASSISTANCE FROM CLINICAL (CITS), WHO IDENTIFIED THE CAUSE OF THE MIRTH DATABASE ISSUE AND CORRECTED THE PROBLEM. THE ROOT CAUSE IS DETERMINED TO BE THE RESULT OF THE SERVER OS LICENSE EXPIRATION (USE ERROR). REVIEW OF THE SERIAL NUMBER HISTORY FINDS NO RECURRENCE OF THE REPORTED ISSUE.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) ARE GETTING COMM LOSS FOR ALL DEVICES, BSMS AND GZS, HOSPITAL-WIDE. THE GWY SERVER WAS OFF SO THE BIOMEDICAL ENGINEER HAD POWERED IT ON. AFTER POWERING ON, NO COMM LOSS AND PATIENT VITALS CAN BE SEEN AT NURSING STATIONS. HOWEVER, THE GWY SERVER FORCEFULLY SHUTDOWN AND THEN DEVICES GO INTO COMM LOSS. THE BIOMEDICAL ENGINEER AT THE HOSPITAL REVIEWED THE SYSTEM EVENT LOG AND SAW THAT THE GWY SERVER LICENSE EXPIRED WHICH RESULTED IN THE FORCED SHUTDOWN. SERVER KEEPS SHUTTING DOWN EVERY TIME THEY BOOT IT UP. NO PATIENT(S) WERE HARMED DURING THIS EVENT. NIHON KOHDEN TECHNICIAN SERVICE EXTENDED THE TRIAL SERVER OS LICENSE WHICH RESOLVED THE ISSUE, SERVICE STAYS POWERED ON, NO MORE COMM LOSS, CAN MONITOR PATIENTS AT NURSING STATIONS. CUSTOMER WILL GET NEW LICENSES FOR GWY SERVER, TEST SERVER, AND PRODUCTION SERVER. 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. CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WAS USED IN CONJUNCTION WITH THE CNS: TRANSMITTER: MODEL #: GZ-130PA SERIAL #: (B)(4) DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: (B)(4). REMOTE NURSE STATION: MODEL #: RNS-6803 SERIAL #: (B)(4) UNIQUE IDENTIFIER (UDI) #: (B)(4). SERVER: A/PWREDGE-R640 SERIAL #: (B)(4). (B)(4)
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) ARE GETTING COMM LOSS FOR ALL DEVICES, BSMS AND GZS, HOSPITAL-WIDE. THE GWY SERVER WAS OFF SO THE BIOMEDICAL ENGINEER HAD POWERED IT ON. AFTER POWERING ON, NO COMM LOSS AND PATIENT VITALS CAN BE SEEN AT NURSING STATIONS. HOWEVER, THE GWY SERVER FORCEFULLY SHUTDOWN AND THEN DEVICES GO INTO COMM LOSS. THE BIOMEDICAL ENGINEER AT THE HOSPITAL REVIEWED THE SYSTEM EVENT LOG AND SAW THAT THE GWY SERVER LICENSE EXPIRED WHICH RESULTED IN THE FORCED SHUTDOWN. SERVER KEEPS SHUTTING DOWN EVERY TIME THEY BOOT IT UP. NO PATIENT(S) WERE HARMED DURING THIS EVENT.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) ARE GETTING COMM LOSS FOR ALL DEVICES, BSMS AND GZS, HOSPITAL-WIDE. THE GWY SERVER WAS OFF SO THE BIOMEDICAL ENGINEER HAD POWERED IT ON. AFTER POWERING ON, NO COMM LOSS AND PATIENT VITALS CAN BE SEEN AT NURSING STATIONS. HOWEVER, THE GWY SERVER FORCEFULLY SHUTDOWN AND THEN DEVICES GO INTO COMM LOSS. THE BIOMEDICAL ENGINEER AT THE HOSPITAL REVIEWED THE SYSTEM EVENT LOG AND SAW THAT THE GWY SERVER LICENSE EXPIRED WHICH RESULTED IN THE FORCED SHUTDOWN. SERVER KEEPS SHUTTING DOWN EVERY TIME THEY BOOT IT UP. NO PATIENT(S) WERE HARMED DURING THIS EVENT.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) ARE GETTING COMM LOSS FOR ALL DEVICES, BSMS AND GZS, HOSPITAL-WIDE. THE GWY SERVER WAS OFF SO THE BIOMEDICAL ENGINEER HAD POWERED IT ON. AFTER POWERING ON, NO COMM LOSS AND PATIENT VITALS CAN BE SEEN AT NURSING STATIONS. HOWEVER, THE GWY SERVER FORCEFULLY SHUTDOWN AND THEN DEVICES GO INTO COMM LOSS. THE BIOMEDICAL ENGINEER AT THE HOSPITAL REVIEWED THE SYSTEM EVENT LOG AND SAW THAT THE GWY SERVER LICENSE EXPIRED WHICH RESULTED IN THE FORCED SHUTDOWN. SERVER KEEPS SHUTTING DOWN EVERY TIME THEY BOOT IT UP. NO PATIENT(S) WERE HARMED DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 886092 | CNS-6801A | CENTRAL MONITOR SYSTEM | MHX | NIHON KOHDEN CORPORATION | CNS-6801A | NA | 04931921131640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | A/PWREDGE-R640| A/PWREDGE-R640| A/PWREDGE-R640| BSM| BSM| BSM| GZ| GZ| GZ| RNS| RNS| RNS |