CNS-6201A
Report
- Report Number
- 8030229-2023-03471
- Event Type
- Malfunction
- Date Received
- May 2, 2023
- Date of Event
- April 3, 2023
- Report Date
- June 12, 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
- MD, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) MONITOR SCREEN WAS BLACK AND WERE UNABLE TO MONITOR PATIENT VITAL SIGNS. THEY USE A SPARE MONITOR AND REBOOTED THE CNS, AND IT GOT STUCK AT THE BOOT PROCESS. THEY ARE GETTING A WAITING MESSAGE ON THE CNS. THEY REMOVED THE HARD DRIVE FROM PORT 0, AND THE CNS WAS ABLE TO BOOTUP NORMALLY. THEY ORDERED ANOTHER HARD DRIVE, AND THE ISSUE WAS RESOLVED. 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. ATTEMPT #1 04/06/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 04/21/2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT THEY DID NOT PROVIDE THE PATIENT AND ADDITIONAL DEVICE INFORMATION AS REQUESTED.
DETAILS OF THE COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) MONITOR SCREEN WAS BLACK AND WERE UNABLE TO MONITOR PATIENT VITAL SIGNS. THEY USE A SPARE MONITOR AND REBOOTED THE CNS, AND IT GOT STUCK AT THE BOOT PROCESS. THEY ARE GETTING A WAITING MESSAGE ON THE CNS. THEY REMOVED THE HARD DRIVE FROM PORT 0, AND THE CNS WAS ABLE TO BOOTUP NORMALLY. THEY ORDERED ANOTHER HARD DRIVE, AND THE ISSUE WAS RESOLVED. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: BASED ON THE INFORMATION REPORTED, WE WERE ABLE TO CONFIRM THE REPORTED ISSUE WAS DUE TO AN ISSUE WITH THE HARD DRIVE, (WHICH WAS REPLACED BY THE FACILITY TO RESOLVE THE ISSUE). UNFORTUNATELY, A DEFINITIVE ROOT CAUSE OF HOW THE ISSUE OCCURRED WITH THE HARD DRIVE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THE HARD DRIVE WAS DAMAGED DUE TO EITHER WEAR AND TEAR FROM USE/AGING, CORRUPTION (DUE TO A USER RELATED ERROR), AND/OR PHYSICAL DAMAGE FROM MISHANDLING. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, THE IDENTIFIED LIKELY CAUSES AND OTHER POTENTIAL CAUSES, (OF SIMILAR ISSUES), ARE LISTED BELOW IN FURTHER DETAIL, FOR REFERENCE. POTENTIAL CAUSES: WE HAVE IDENTIFIED SOME POTENTIAL CAUSES OF THE CNS DEVICE EXPERIENCING APP ADVISORY ERROR MESSAGE ISSUES, (INCLUDING ISSUES WHERE THE CNS HAD A HARD REBOOT AND AN APP ADVISORY ERROR MESSAGES DISPLAYED), WHICH ARE TYPICALLY DUE TO, BUT ARE NOT LIMITED TO, USER RELATED SETUP ERROR ISSUES AND/OR SOFTWARE/NETWORK/CONNECTIVITY/ENVIRONMENTAL/IT ISSUES, SOFTWARE OR FILE CORRUPTION, (TYPICALLY DUE TO USER RELATED ERRORS, UNGRACEFUL SHUTDOWNS, UNEXPECTED SHUTDOWNS, POWER SURGES, POWER ISSUES, OR POWER OUTAGES), HARD DISK DRIVE DAMAGE, (DUE TO PHYSICAL DAMAGE, CORRUPTION, OR UNGRACEFUL OR UNEXPECTED SHUTDOWNS), AND/OR OTHER DAMAGE TO THE DEVICE OR ITS COMPONENTS. THESE IDENTIFIED POTENTIAL CAUSES NOT LIMITED TO AND EXPLAINED IN FURTHER DETAIL BELOW. · HARD DRIVE FAILURES: MOST COMMONLY, HARD DRIVE FAILURES WILL RESULT IN SPONTANEOUS SHUTDOWN OR REBOOT OF THE DEVICE. POTENTIAL CAUSES OF HARD DRIVE FAILURES INCLUDE NORMAL HARD DRIVE FAILURES OR FAILURES RESULTING FROM FREQUENT POWER LOSS, INAPPROPRIATE SHUTDOWN/REBOOT PROCEDURE. THE OPERATOR MANUAL OUTLINES SPECIFIC STEPS TO PERFORM A DEVICE SHUTDOWN OR REBOOT. AS WITH ANY DEVICE, THE HARD DRIVE SUPPLIED WITH THE CNS HAS LIMITED DURABILITY. IT IS THE MANUFACTURER'S RECOMMENDATION TO HAVE HARD DRIVES REPLACED EVERY TWO YEARS OR 20,000 HOURS OF USE. AS A MAINTENANCE REMINDER, THE USER IS PROMPTED WITH A MESSAGE ON THE BOTTOM RIGHT OF THE CNS SCREEN TO CHECK HARD DRIVE STATUS ONCE USAGE HAS REACHED 20,000 HOURS. · HDD PORT ERROR MESSAGES: THESE ERROR MESSAGES CAN OCCUR ON THE CNS WHEN THE USED HOURS OF THE HDD EXCEED 20,000 HOURS. AN HDD PORT ERROR MESSAGE PROMPTS THE USER TO CHECK THE CONDITION OF THE HDD WHEN IT HAS EXCEEDED 20,000 HOURS OF RUNTIME. USERS MAY REPLACE THE HDD OR MAY CONTINUE TO USE THE HDD AFTER INSPECTING THE CONDITION OF THE HDD. FAILURE TO REPLACE THE HDD OR INSPECT THE HDD MAY LEAD TO HDD FAILURE. IF THERE IS NO TRUE ISSUE WITH THE HDD THE TIMER CAN BE RESET, TO RESOLVE THE ISSUE, OR AFTER THE REPLACEMENT HAS BEEN COMPLETED, THE TIMER CAN ALSO BE RESET. · USER RELATED SETUP/SETTINGS/INSTALLATION ERROR ISSUES: USER RELATED ERRORS, (INCLUDING INCORRECT SETTINGS OF THE SYSTEM, INCORRECT SETUP/INSTALLATION, UNGRACEFUL SHUTDOWNS, OR UNEXPECTED SHUTDOWNS), CAN LEAD TO DAMAGE TO SENSITIVE COMPONENTS SUCH AS THE HDDS AND CAN LEAD TO ERROR MESSAGES BEING DISPLAYED, SUCH AS COMMUNICATION ERRORS OR NETWORK DISCONNECT ERRORS. ALSO, SET UP AND INSTALLATION ISSUES, (SUCH AS INCORRECT SETTINGS, MAINTENANCE AND CALIBRATION ISSUES, SOFTWARE RELATED ISSUES LEADING TO DATA FLOW ISSUES, INCORRECT CONNECTION, SETUP OR CONNECTION OF CABLES, MONITORS, DEVICES ECT.), CAN LEAD TO A VARIETY OF DIFFERENT FAILURES. IF A SETUP/INSTALLATION ISSUE OCCURS, IT IS TYPICALLY DUE TO A USER RELATED ERROR AND/OR FILE/SOFTWARE CORRUPTION (SEE BELOW). USER RELATED SETUP AND INSTALLATION ISSUES CAN ALSO LEAD TO THE CNS DEVICE EXPERIENCING MULTIPLE ISSUES AND ERROR MESSAGES BEING DISPLAYED. · POWER LOSS/HARD DRIVE ISSUES: WHEN THE CNS EXPERIENCES A POWER LOSS, IT CAN BE CAUSED BY A VARIETY OF EVENTS. THESE EVENTS INCLUDE USER RELATED UNGRACEFUL EXITS OR UNEXPECTED SHUTDOWNS, POWER OUTAGES, GENERATOR TESTS, UNINTERRUPTABLE POWER SUPPLY (FAILURE) OR POWER FAILURE AND/OR POWER SURGES. THESE ARE ENVIRONMENTAL FACTORS IMPACT DEVICE FUNCTIONALITY AND CAUSE DAMAGE TO COMPONENTS, HARDWARE AND SENSITIVE HARD DRIVES AND LEAD TO FAILURES AND THE DISPLAY OR APP ADVISORY ERRORS. · DAMAGE ISSUES (INCLUDING HARD DISK DRIVE DAMAGE DUE TO CORRUPTION): DAMAGE TO THE DEVICE OR ITS COMPONENTS OR HARDWARE USED IN CONJUNCTION WITH THE DEVICE CAN LEAD TO APP ADVISORY OR ERROR MESSAGE ISSUE. DAMAGE CAN INCLUDE HARD DISK DRIVE DAMAGE, WHICH CAN OCCUR DUE TO FILE CORRUPTION, SOFTWARE CORRUPTION, POWER SURGES OR POWER OUTAGES AT THE FACILITY, WHICH CAN ALL LEAD TO PERMANENT DAMAGE TO THE SENSITIVE HARD DISK DRIVE. · SOFTWARE AND/OR FILE CORRUPTION/UNGRACEFUL EXITS/IMPROPER SHUTDOWN ISSUES: SOFTWARE AND/OR FILE CORRUPTION ISSUES MAY AFFECT THE OPERATION OF THE SYSTEM AND LEAD TO APPLICATION ADVISORY ERRORS. SHOULD THE SOFTWARE AND/OR FILE BECOME CORRUPT, RE-INSTALLING THE FILE AND/OR SOFTWARE WOULD RESOLVE THE ISSUE. THE MOST COMMON ROOT CAUSES OF SOFTWARE AND/OR FILE CORRUPTION ARE UNGRACEFUL EXITS OR IMPROPER SHUTDOWNS. UNGRACEFUL EXITS OR POWER LOSS DURING SOFTWARE AND/OR OPERATIONS ARE LIKELY TO RESULT IN CORRUPTION OF FILES AND/OR SOFTWARE. IN SOME CASE, CORRUPTION ISSUES CAN LEAD TO DAMAGE TO SENSITIVE COMPONENTS, SUCH AS HARD DISK DRIVE FAILURES AND/OR DAMAGE (SEE DAMAGE SECTION BELOW). · SOFTWARE/NETWORK/CONNECTIVITY/ENVIRONMENTAL/IT (INFORMATION TECHNOLOGY) ISSUES: SOFTWARE ISSUES, A BAD NETWORK CONNECTION, ENVIRONMENTAL ISSUES, AND IT ISSUES MAY CAUSE ISSUES WITH THE SYSTEMS, SUCH AS HAVING INSTALLATION, SETUP OR STARTUP ISSUES, WHICH CAN ALSO INCLUDE AN INTERMITTENT BLANK OR FLASHING SCREEN, ERROR MESSAGED BEING DISPLAYED, BLACK SCREEN, BOOTUP ISSUES, OR SIGNAL/COMMUNICATION LOSS ISSUES, OR POWER RELATED ISSUES, WHICH CAN BE AN INDICATION THAT THE DEVICE IS NOT BEING DETECTING ON THE NETWORK. IN SOME CASES, POWER OUTAGES MAY CAUSE INTERMITTENT NETWORK CONNECTIVITY ISSUE WITH DEVICES AS WELL, DURING THE INSTALLATION AND/OR SETUP PROCESS. THESE POTENTIAL CAUSES CAN BE REMEDIED BY ENSURING THE CORRECT SETTINGS ARE ON THE DEVICE AND/OR REINSTALLING THE BATTERY/CONNECTION AND POWER CABLES AND BY REBOOTING THE DEVICE TO RE-ESTABLISH THE PROPER CONNECTING BETWEEN THE DEVICES. IN SOME INSTANCES, THE USER MAY NEED TO REPLACE POSSIBLE WORN COMPONENTS (SUCH AS BATTERIES/CABLES OR INTERNAL COMPONENTS), DUE TO WEAR AND TEAR FROM NORMAL USE OF THE DEVICE. · SOFTWARE/IT (INFORMATION TECHNOLOGY) ISSUES: (SUCH AS USE OF INCOMPATIBLE OR OUTDATED SOFTWARE): IF AN OUTDATED VERSION OF SOFTWARE IS BEING USED, OR IS INCOMPATIBLE WITH OTHER DEVICES BEING USED, (DUE TO A USER ERROR), OR A FACILITY IT RELATED ISSUE OCCURS, IT CAN LEAD TO THE CNS DEVICE EXPERIENCING MULTIPLE ISSUES. · POWER RELATED/STARTUP ISSUES/SPONTANEOUS SHUTDOWN POWER RELATED, STARTUP, AND SPONTANEOUS SHUTDOWN ISSUES: ISSUES DURING THE INSTALLATION, SETUP PROCESS OR USE OF THE DEVICE, CAN OCCUR DUE TO DEVICE OR COMPONENT DAMAGE OR DUE TO A POWER SURGE AT THE FACILITY, WHICH CAN LEAD TO COMPONENT DAMAGE OR INTERMITTENT POWER RELATED ISSUES DURING THE INSTALLATION, SETUP PROCESS OR STARTUP PROCESS, DUE TO USER RELATED SETUP ERRORS, WHICH CAN ALSO LEAD TO THE CNS DEVICE EXPERIENCING MULTIPLE ISSUES. · COMMUNICATION OR SIGNAL LOSS ISSUES (DEVICE NOT CONNECTING, CONNECTION LOSS ISSUE, FACILITY/ENVIRONMENTAL OR IT (INFORMATION TECHNOLOGY) ISSUES): IF A DEVICE HAS A COMMUNICATION OR SIGNAL LOSS ISSUES, TYPICALLY IT IS DUE TO A FACILITY NETWORK CONNECTIVITY ISSUE, FACILITY SERVER COMMUNICATION ISSUE OR DUE TO A FACILITY IT (INFORMATION TECHNOLOGY) RELATED ISSUE. COMMUNICATION AND SIGNAL LOSS CAN ALSO OCCUR DUE TO A USER RELATED SETUP ERROR OR IN SOME CASES, A DEVICE OR COMPONENT COULD BE DAMAGED, DUE TO DROPPAGE, MISHANDLING OR DUE TO MECHANICAL STRESS OR WEAR AND TEAR, DURING NORMAL USE OF THE DEVICE, WHICH CAN ALSO LEAD TO. THE CNS DEVICE EXPERIENCED MULTIPLE ISSUES WITH THE DEVICE. THE FOLLOWING FIELDS ARE NOT APPLICABLE (NA) TO THE MDR REPORT: B2 D4 LOT NUMBER & EXPIRATION D6A - D6B D7B F1 - F14 G4 DEVICE BLA NUMBER G5 G7 H2 H7 H9 THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. A2 - A6 B6 - B7 D10 CONCOMITANT MEDICAL DEVICE ATTEMPT #1 (B)(6) 2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. NO REPLY WAS RECEIVED. ATTEMPT #2 (B)(6) 2023 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT THEY DID NOT PROVIDE THE PATIENT AND ADDITIONAL DEVICE INFORMATION AS REQUESTED. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES H10 ADDITIONAL MANUFACTURER NARRATIVE.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) MONITOR SCREEN WAS BLACK AND WERE UNABLE TO MONITOR PATIENT VITAL SIGNS. THEY USE A SPARE MONITOR AND REBOOTED THE CNS, AND IT GOT STUCK AT THE BOOT PROCESS. THEY ARE GETTING A WAITING MESSAGE ON THE CNS. THEY REMOVED THE HARD DRIVE FROM PORT 0, AND THE CNS WAS ABLE TO BOOTUP NORMALLY. THEY ORDERED ANOTHER HARD DRIVE, AND THE ISSUE WAS RESOLVED. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) MONITOR SCREEN WAS BLACK AND WERE UNABLE TO MONITOR PATIENT VITAL SIGNS. THEY USE A SPARE MONITOR AND REBOOTED THE CNS, AND IT GOT STUCK AT THE BOOT PROCESS. THEY ARE GETTING A WAITING MESSAGE ON THE CNS. THEY REMOVED THE HARD DRIVE FROM PORT 0, AND THE CNS WAS ABLE TO BOOTUP NORMALLY. THEY ORDERED ANOTHER HARD DRIVE, AND THE ISSUE WAS RESOLVED. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 247209 | CNS-6201A | CENTRAL MONITOR SYSTEM | MHX | NIHON KOHDEN CORPORATION | CNS-6201A | NA | 04931921114131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |