CNS-6201A
Report
- Report Number
- 8030229-2023-03647
- Event Type
- Malfunction
- Date Received
- July 10, 2023
- Date of Event
- June 13, 2023
- Report Date
- September 19, 2023
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- MHX
- UDI-DI
- 04931921114131
- 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 NURSES STATION (CNS) HAD TWO INSTANCES WHERE THE CNS SPONTANEOUSLY REBOOTED. THE FIRST OCCURRENCE WAS ON 06/09/2023, AND THE SECOND OCCURRED ON THE NIGHT OF 6/12/2023. THE BME ATTEMPTED TO EXPORT THE CRASH DUMP FILES, BUT THE CNS FROZE AND FORCED THEM TO PERFORM A HARD REBOOT. AFTER TROUBLESHOOTING WITH THE TECHNICAL SUPPORT (TS) TEAM, IT WAS DETERMINED THAT THE HDDS NEEDED REPLACING, WHICH THE BME DID IN-HOUSE. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE CUSTOMER REPLACED THE HDDS OF THE DEVICE, AND NK TS ASSISTED THE CUSTOMER IN REGISTERING THE SOFTWARE AND UNLOCKING 32 BEDS ON THE CNS. AFTER THIS WAS PERFORMED, NO ISSUES REGARDING SPONTANEOUS REBOOT WERE REPORTED. AS THE ISSUE WAS RESOLVED BY REPLACING THE HDDS OF THE DEVICE, A POSSIBLE CAUSE OF THE ISSUE IS HDD FAILURE. THE ROOT CAUSE AS TO WHY THE HDDS FAILED COULD NOT BE IDENTIFIED. A POSSIBLE CAUSE OF HDD FAILURE IS WEAR AND TEAR. HDD IS A WEAR AND TEAR COMPONENT OF THE CNS. THE EXPECTED LIFE OF HDDS IS 20,000 HOURS OF RUNTIME (APPROX. TWO YEARS). ONCE 20,000 HOURS OF RUN TIME HAS BEEN MET, THE USER WILL RECEIVE AN HDD PORT ERROR MESSAGE ON THE CNS. AN HDD PORT ERROR MESSAGE PROMPTS THE USER TO CHECK THE CONDITION OF THE HDDS WHEN IT HAS EXCEEDED 20,000 HOURS OF RUNTIME. USERS MAY REPLACE THE HDDS OR MAY CONTINUE TO USE THE HDD AFTER THE INSPECTION OF THE CONDITION OF THE HDD. FAILURE TO REPLACE OR INSPECT THE HDD MAY LEAD TO HDD FAILURE. TO MITIGATE THE RISKS FROM HDD FAILURES, THE CNS IS DESIGNED WITH REDUNDANT ARRAY OF INDEPENDENT DISKS (RAID) SO THAT IF ONE HDD FAILS, ANOTHER HDD CAN TAKE OVER. THE MANUFACTURER ALSO PROVIDED ALL SITES WITH A ".BAT" FILE PATCH, WHICH HELPS RECOGNIZE HARD DISK FAILURE AND PROVIDES A WARNING MESSAGE WHEN A HARD DRIVE BEGINS TO FAIL. THE MANUFACTURER HAD ALSO UPDATED THE DEVICE MANUFACTURING PROCESS TO INCORPORATE THE ".BAT" FILE FUNCTION. LABELING AND OPERATOR'S MANUAL FOR VARIOUS GENERATIONS OF THE CNS RECOMMEND PERIODIC MAINTENANCE OR REPLACEMENT OF HARD DISK DRIVES. THE COMPLAINT UNIT HAS BEEN IN SERVICE SINCE 05/29/2017, AND NO OTHER REPORTS HAVE BEEN MADE REGARDING SPONTANEOUS REBOOTS AGAINST THIS DEVICE. THE HDDS OF THE DEVICE HAVE EXCEEDED ITS EXPECTED LIFE SPAN OF 20,000 HOURS. NK WILL CONTINUE TO TREND AND MONITOR THE REPORTED ISSUE. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED. ATTEMPT #1 06/15/2023 EMAILED BME FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 06/20/2023 EMAILED BME FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #3 06/27/2023 EMAILED BME FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE CNS: BSM(S): MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NA. TRANSMITTER(S): MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NA.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSES STATION (CNS) HAD TWO INSTANCES WHERE THE CNS SPONTANEOUSLY REBOOTED. THE FIRST OCCURRENCE WAS ON (B)(6) 2023, AND THE SECOND OCCURRED ON THE NIGHT OF (B)(6) 2023. THE BME ATTEMPTED TO EXPORT THE CRASH DUMP FILES, BUT THE CNS FROZE AND FORCED THEM TO PERFORM A HARD REBOOT. AFTER TROUBLESHOOTING WITH THE TECHNICAL SUPPORT (TS) TEAM, IT WAS DETERMINED TO REPLACE THE HDD OR SEND THE UNIT IN FOR REPAIR. THE BME WANTED TO REPLACE THE HDD. 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. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED. ATTEMPT #1 06/15/2023 EMAILED BME FOR ALL ITEMS UNDER THE NO INFORMATION SECTION AND THE CONCOMITANT MEDICAL DEVICES. NO REPLY WAS RECEIVED. ATTEMPT #2 06/20/2023 EMAILED BME FOR ALL ITEMS UNDER THE NO INFORMATION SECTION AND THE CONCOMITANT MEDICAL DEVICES. NO REPLY WAS RECEIVED. ATTEMPT #3 06/27/2023 EMAILED BME FOR ALL ITEMS UNDER THE NO INFORMATION SECTION AND THE CONCOMITANT MEDICAL DEVICES. NO REPLY WAS RECEIVED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE CNS: BSM(S): MODEL #: NI SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: NA; TRANSMITTER(S): MODEL #: NI SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: NA.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) HAD TWO INSTANCES WHERE THE CNS SPONTANEOUSLY REBOOTED. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) HAD TWO INSTANCES WHERE THE CNS SPONTANEOUSLY REBOOTED. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1586638 | CNS-6201A | CENTRAL MONITOR SYSTEM | MHX | NIHON KOHDEN CORPORATION | CNS-6201A | NA | 04931921114131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | BSM(S)| BSM(S)| TRANSMITTER(S)| TRANSMITTER(S) |