CNS-6201A
Report
- Report Number
- 8030229-2019-00030
- Event Type
- Malfunction
- Date Received
- January 10, 2019
- Date of Event
- December 20, 2018
- Report Date
- January 30, 2020
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- MHX
- UDI-DI
- 04931921114131
- PMA / PMN Number
- K102376
- Removal / Correction Number
- NOT APPLICABLE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
DETAILS OF THE COMPLAINT: CUSTOMER REPORTED THAT THE UPS FOR THEIR CNS APPEARED TO HAVE FAILED. WHEN THE CNS POWERED BACK ON WITHOUT THE UPS, THE SYSTEM WAS STUCK ON THE LOADING OPERATING SYSTEM SCREEN AND WOULDN'T MOVE PAST THE CNS-6201 SPLASH SCREEN. SERVICE REQUESTED: HARD DRIVE EXCHANGE. SERVICE PERFORMED: HARD DRIVE EXCHANGE. INVESTIGATION RESULT(S): TECHNICAL SUPPORT ADVISED THE USER THAT THEY WOULD NEED TO TROUBLESHOOT THE HARD DRIVES (HDD) TO DETERMINE IF IT WAS A SINGLE HDD FAILURE OR A SYSTEM IMAGE ISSUE. THE USER REPORTED AFTER REMOVING THE SECONDARY HDD FROM THE BOTTOM PORT THE CNS BOOTED UP FINE. THE FAILED HARD DRIVE WAS SENT IN AND EXCHANGED FOR A NEW ONE. THE DEFECTIVE HARD DRIVE WAS SCRAPPED. THIS UPS IS PROVIDED BY AMETEK POWERVAR, WHICH IS NOT A PART OF NK. PER MANUFACTURER'S MANUAL, THE BATTERIES ARE DESIGNED TO LAST FROM 2-5 YEARS BUT THEIR ACTUAL LIFE SPAN WILL DEPEND ON SEVERAL FACTORS INCLUDING HOW OFTEN POWER OUTAGES OCCUR, HOW LONG POWER OUTAGES LAST, AND THE TEMPERATURE OF THE ENVIRONMENT IN WHICH THE UPS OPERATES. THE UPS IS INTENDED TO BE USED AS A BACK-UP POWER SOURCE IN CASE AC POWER WAS LOST AND IS NOT MEANT TO BE USED AS A STAND-ALONE POWER SUPPLY. POSSIBLE ROOT CAUSES FOR UPS FAILURE ARE EITHER BATTERIES FAILING OR END OF LIFE SPAN DUE TO USE. THE ROOT CAUSE OF THE CNS STARTUP ISSUE WAS FOUND TO BE A DEFECTIVE HDD FROM THE BOTTOM PORT OF THE CNS. REMOVING THE DEFECTIVE HDD RESOLVED THE CNS STARTUP ISSUE.
COMPLAINT INFORMATION: ON (B)(6) 202018, CUSTOMER AT WINTHROP UNIVERSITY HOSPITAL REPORTED CNS GOT STUCK ON STARTUP SCREEN ON PU-621RA WITH SERIAL# (B)(6) SERVICE REQUESTED: ASSISTANCE IN TROUBLESHOOTING SERVICE PERFORMED: NKTS COULD DUPLICATE THE ISSUE AND ASSISTED IN TROUBLESHOOTING. UPS OF REPORTED CNS DEVICE FAILED DUE TO WHICH CNS WAS POWERED BACK ON WITHOUT UPS AND CNS SCREEN WAS STUCK ON LOADING OPERATING SYSTEM SCREEN. NKTS SUGGESTED CUSTOMER TO TROUBLESHOOT THE ISSUE BY REMOVING THE DRIVE FROM THE SECONDARY/BOTTOM PORT AND BOOT WITH THE PRIMARY DRIVE THEN TEST THE SECONDARY DRIVE BY REPLACING THE PRIMARY DRIVE IN THE TOP PORT WITH IT. CUSTOMER CALLED BACK TO INFORM THAT THE ISSUE WAS RESOLVED AFTER REMOVING THE SECONDARY HDD FROM BOTTOM PORT OF THE SYSTEM AFTER WHICH THE SYSTEM BOOTED UP NORMALLY. INVESTIGATION RESULT: NATURE OF COMPLAINT: UPS FAILURE CAUSING HDD FAILURE. COMPLAINT PATTERN: REVIEW OF DEVICE HISTORY FOUND NO SIMILAR INCIDENTS ON UPS FAILURE REVIEW OF CUSTOMER'S ACCOUNT FOUND NO SIMILAR INCIDENTS ON UPS FAILURE REVIEW OF DEVICE FAMILY HISTORY PU-621RA, FOUND FOLLOWING 39 SIMILAR REPORTED COMPLAINTS RELATED TO UPS FAILURE: · TICKET# 70910 WITH NOTIFICATION # 300185817 : ON (B)(6) 2019 CUSTOMER AT (B)(6) MEDICAL CENTER REPORTED ISSUE OF UPS FOR CENTRAL NURSING STATION WENT DOWN CAUSING CNS TO POW ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE · TICKET# 68780 WITH NOTIFICATION # 300182459 : ON (B)(6) 2019 CUSTOMER AT (B)(6) HEALTH ATTN: ACCOUNTS PAYABLE REPORTED ISSUE OF UPS FAILED ON PU-621RA WITH SERIAL# 1895 THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# 67783 WITH NOTIFICATION # 300181180 : ON (B)(6) 2019 CUSTOMER AT (B)(6) MEMORIAL HOSPITAL REPORTED ISSUE OF UPS ISSUE 300181180 ON PU-621RA WITH SERIAL# 1894 THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# 62481 WITH NOTIFICATION # 300175785 : ON (B)(6) 2019 CUSTOMER AT (B)(6) HEALTH SYSTEM ATTN: ACCOUNTS PAYABLE REPORTED ISSUE OF PU-621RA UPS FAILURE (TRB) ON PU-621RA WITH SERIAL# 980 THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# 61831 WITH NOTIFICATION # 300175275 : ON (B)(6) 2019 CUSTOMER AT (B)(6) REPORTED ISSUE OF UPS ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300172207 : ON (B)(6) 2019 CUSTOMER AT OSF (B)(6) HOSPITAL REPORTED ISSUE OF PU-621RA UPS FAILURE (TRB) ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# (B)(4)WITH NOTIFICATION # 300168903 : ON (B)(6) 2019 CUSTOMER AT (B)(6) HOSPITAL REPORTED ISSUE OF PU-621RA UPS FAILED (TRB) ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# (B)(4)WITH NOTIFICATION # 300165465 : ON (B)(6) 2019 CUSTOMER AT (B)(6) MEMORIAL HOSPITAL REPORTED ISSUE OF UPS WILL NOT POWER ON ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300164075 : ON (B)(6) 2019 CUSTOMER AT (B)(6) ATTN: ACCOUNTS PAYABLE REPORTED ISSUE OF PU-621RA UPS FAILURE (TRB) ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300160590 : ON (B)(6) 2019 CUSTOMER AT (B)(6) HEALTH ATTN: ACCOUNTS PAYABLE REPORTED ISSUE OF PU-621RA FAILED UPS (EXC) ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300157721 : ON (B)(6) /2019 CUSTOMER AT (B)(6) MEMORIAL HOSPITAL REPORTED ISSUE OF UPS FAILURE - PU-621RA - S/N: (B)(6) ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# (B)(4)WITH NOTIFICATION # 300155076 : ON (B)(6) 2019 CUSTOMER AT (B)(6) MEMORIAL HOSPITAL REPORTED ISSUE OF UPS FAILED AGAIN ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300154677 : ON (B)(6) 2018 CUSTOMER AT (B)(6) REGIONAL MEDICAL CTR REPORTED ISSUE OF UPS ISSUE ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300153213 : ON (B)(6) 2018 CUSTOMER AT (B)(6) MEMORIAL HOSPITAL REPORTED ISSUE OF CNS LOST POWER - UPS FAILURE - CNS-6201 - S/N: (B)(6) ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300151443 : ON (B)(6) /2018 CUSTOMER AT (B)(6) HOSPITAL REPORTED ISSUE OF FAILED UPS ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# (B)(4)WITH NOTIFICATION # 300148969 : ON (B)(6) /2018 CUSTOMER AT FIRSTHEALTH (B)(6) REPORTED ISSUE OF FAILED UPS ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE .. · TICKET# (B)(4)WITH NOTIFICATION # 300142457 : ON (B)(6) 2018 CUSTOMER AT (B)(6) HOSPITAL, INC. REPORTED ISSUE OF UPS FAILED DUE TO MULTIPLE POWER OUTAGES ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE · TICKET# (B)(4)WITH NOTIFICATION # 300142117 : ON (B)(6) 2018 CUSTOMER AT (B)(6) HOSPITAL, INC. REPORTED ISSUE OF PU-621RA UPS IS OUT (TRB) ON PU-621RA WITH SERIAL# NO_SERIAL THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# (B)(4)WITH NOTIFICATION # 300140978 : ON (B)(6) 2018 CUSTOMER AT (B)(6) MEMORIAL HOSPITAL REPORTED ISSUE OF PU-621RA UPS IS OUT (EXC) ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# (B)(4)WITH NOTIFICATION # 300136968 : ON (B)(6) /2018 CUSTOMER AT (B)(6) MEDICAL CENTER REPORTED ISSUE OF UPS FAILURE ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300136264 : ON (B)(6) 2018 CUSTOMER AT (B)(6) MEMORIAL HOSPITAL REPORTED ISSUE OF OBF UPS ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# (B)(4)WITH NOTIFICATION # 300135198 : ON (B)(6) 2018 CUSTOMER AT (B)(6) MEMORIAL HOSPITAL REPORTED ISSUE OF UPS ISSUES ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# (B)(4)WITH NOTIFICATION # 300133478 : ON (B)(6) 2018 CUSTOMER AT (B)(6) HEALTH SYSTEM ATTN: ACCOUNTS PAYABLE REPORTED ISSUE OF UPS BAD ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# 35101 WITH NOTIFICATION # 300132991 : ON (B)(6) 2018 CUSTOMER AT (B)(6) REPORTED ISSUE OF UPS IS NOT HOLDING A CHARGE ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILUR.E · TICKET# (B)(4)WITH NOTIFICATION # 300132848 : ON (B)(6) 2018 CUSTOMER AT (B)(6) HEALTH REPORTED ISSUE OF UPS FAILURE ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300129839 : ON (B)(6) 2018 CUSTOMER AT (B)(6) HOSPITAL REPORTED ISSUE OF FAILED UPS ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300128502 : ON (B)(6) 2018 CUSTOMER AT (B)(6) MED CENTER REPORTED ISSUE OF UPS FAILED ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300128277 : ON (B)(6) 2018 CUSTOMER AT (B)(6) CORP. REPORTED ISSUE OF OUT OF BOX UPS FAILURE ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# (B)(4)WITH NOTIFICATION # 300127945 : ON (B)(6) 2018 CUSTOMER AT (B)(6) MED CENTER REPORTED ISSUE OF UPS WILL NOT POWER ON ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# (B)(4)WITH NOTIFICATION # 300126516 : ON (B)(6) /2018 CUSTOMER AT (B)(6) HOSPITAL REPORTED ISSUE OF UPS FAILURE ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# (B)(4)WITH NOTIFICATION # 300124014 : ON (B)(6) 2018 CUSTOMER AT (B)(6) CENTER REPORTED ISSUE OF UPS EXCHANGE ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# (B)(4)WITH NOTIFICATION # 300123638 : ON (B)(6) 2018 CUSTOMER AT (B)(6) HOSPITAL REPORTED ISSUE OF BAD UPS ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300121098 : ON (B)(6) 2018 CUSTOMER AT (B)(6) ,LLC. REPORTED ISSUE OF FAILED UPS ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300120764 : ON (B)(6) 2018 CUSTOMER AT (B)(6) HOSPITAL REPORTED ISSUE OF UPS POWER ISSUES ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300153807 : ON (B)(6) 2018 CUSTOMER AT ((B)(6) HOSPITAL REPORTED ISSUE OF CNS SHUT DOWN DUE TO A UPS FAILURE ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# (B)(4)WITH NOTIFICATION # 300154299 : ON (B)(6) 2018 CUSTOMER AT (B)(6) MED CENTER REPORTED ISSUE OF UPS FAILED AND THE CNS POWERED OFF ON PU-621RA WITH SERIAL# THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300163994 : ON (B)(6) 2019 CUSTOMER AT (B)(6) HEALTH ATTN: ACCOUNTS PAYABLE REPORTED ISSUE OF UPS FAILED AND THE CNS POWERED OFF ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE . · TICKET# (B)(4)WITH NOTIFICATION # 300125188 : ON (B)(6) 2019 CUSTOMER AT SOUTHERN (B)(6) MED CTR REPORTED ISSUE OF UPS FAILED ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE. · TICKET# (B)(4)WITH NOTIFICATION # 300151886 : ON (B)(6) 2018 CUSTOMER AT (B)(6) CENTER REPORTED ISSUE OF UPS FAILED AND THE CNS POWERED OFF ON PU-621RA WITH SERIAL# (B)(6) THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE UPS FAILURE ROOT CAUSE ANALYSIS METHOD AND RESULT: ROOT CAUSE ANALYSIS METHOD USED IN THIS COMPLAINT IS: [?] FISH BONE OR CAUSE AND EFFECT OR ISHIKAWA DIAGRAM FOR UPS FAILURE, TO IDENTIFY POSSIBLE CAUSES FOR FAILURE OF UPS: · MACHINE: O INHERENT LIMITATIONS E.G. SINGLE DEVICE CONNECTION, LIMITED BATTERY CAPACITY, ETC. · MATERIAL: O CONDITION OF UPS OUTLET O CONDITION OF CONNECTED CABLES O BATTERY NEEDING REPLACEMENT · ENVIRONMENT: O LOCATION OF UPS O FREQUENCY OF POWER OUTAGE O UNCERTAIN DURATION OF POWER OUTAGE O WALL CONDITION OR AC OUTLET · PERSON: O LACK OF USER EDUCATION ON LIMITATIONS OF UPS O COMMUNICATION GAP ON MAINTENANCE BETWEEN NK AND VENDOR O USER ERROR OF FREQUENT DISCONNECTION OF UPS FROM AC POWER · METHOD: O MANUAL REQUIREMENT O USING POWER STRIP OR EXTENSION CORDS O PROCESS OF USAGE BY USER O LACK OF MAINTENANCE [?] 5 WHY'S FOR CNS FAILURE WHICH IS DESCRIBED AS BELOW: · WHY DID THE CUSTOMER REPORT CNS GOT STUCK ON STARTUP SCREEN? O BECAUSE ONE OF THE TWO HARD DRIVES FAILED. · WHY DID ONE OF THE TWO HARD DRIVES FAIL IN THE CNS? O BECAUSE CNS HAD TO BE CONNECTED TO DIRECT AC FOR POWER SUPPLY . · WHY CNS HAD TO BE CONNECTED TO DIRECT AC FOR POWER SUPPLY? O BECAUSE UPS CONNECTED TO THE CNS FAILED. · WHY DID THE UPS CONNECT TO THE CNS FAIL? O THE ROOT CAUSE OF THE UPS FAILURE COULD NOT BE IDENTIFIED, HOWEVER POSSIBLE CAUSE OF UPS FAILURE HAS BEEN LISTED ABOVE AS A PART OF ISHIKAWA/ FISHBONE / CAUSE AND EFFECT DIAGRAM. UPS IS OUTSOURCED FROM AMETEK POWERVAR, WHICH IS NOT A PART OF NK DEVICES. PER MANUFACTURER'S MANUAL, THE BATTERIES ARE DESIGNED TO LAST FROM 2-5 YEARS, BUT THEIR ACTUAL LIFE SPAN WILL DEPEND ON SEVERAL FACTORS INCLUDING HOW OFTEN POWER OUTAGES OCCUR, HOW LONG POWER OUTAGES LAST, AND THE TEMPERATURE OF THE ENVIRONMENT IN WHICH THE UPS OPERATES. THE UPS IS INTENDED TO BE USED AS A BACK-UP POWER SOURCE IN CASE AC POWER WAS LOST AND IS NOT MEANT TO BE USED AS A STAND-ALONE POWER SUPPLY. RESULT: ROOT CAUSE OF CNS STARTUP SCREEN STUCK WAS IDENTIFIED TO BE HARD DISK FAILURE AS CNS WAS POWERED BACK ON WITHOUT UPS. HOWEVER, THE ROOT CAUSE OF UPS FAILURE COULD NOT BE IDENTIFIED AS UPS IS OUTSOURCED BY NK. THE POSSIBLE CAUSES OF THE UPS FAILURE ARE LISTED IN ISHIKAWA/ FISHBONE / CAUSE AND EFFECT DIAGRAM DESCRIBED ABOVE. THE WARRANTY OF CNS DEVICE EXPIRED ON 07/30/2019. RISK ASSESSMENT: AS DOCUMENTED IN THE QUALITY COMPLAINT INVESTIGATIONS WORK INSTRUCTION, WITH DOCUMENT ID: SOP06-075, · SEVERITY OF THE ISSUE: MODERATE . O RATIONALE: THE RISKS OF CNS DEVICE BEING OFF DUE TO POWER ISSUE RESULTING FROM UPS FAILURE IS THAT THERE IS A LOSS OF CENTRAL MONITORING OF PATIENT'S VITAL SIGNS AND WAVEFORMS, ALONG WITH OTHER PATIENT INFORMATION. THE CNS MONITORS BOTH BEDSIDE AND WIRELESS TELEMETRY TRANSMITTERS DEVICES. BEDSIDE MONITORS HAVE LOCAL ALARM FUNCTIONS, BOTH AUDIBLE AND VISUAL, WHILE WIRELESS TELEMETRY TRANSMITTERS DISPLAY COMPRESSED WAVEFORM AND NUMERIC DATA OF THE LATEST 10 MINUTES. WHEN THE CNS IS POWERED OFF, THE ISSUE IS IMMEDIATELY NOTICEABLE BY THE ATTENDING CLINICIAN. IF ALTERNATE MONITORING MEANS ARE NOT AVAILABLE FOR THE WIRELESS TELEMETRY PATIENTS, THERE IS A POSSIBLE LOSS OF PATIENT MONITORING. · PROBABILITY OF THE ISSUE: UNLIKELY. RATIONALE: THE PROBABILITY OF THIS ISSUE RE-OCCURRING IS DERIVED FROM C4C DATA. DATA WAS PULLED ON JAN 22, 2020. OUT OF 33046 RECORDS, THE TICKET TITLE IS FILTERED FOR "UPS" KEYWORD. USER EDUCATION HAS BEEN OPTED OUT FROM SERVICE AND INCIDENT CATEGORIES. FILE STATUS IS FILTERED OUT VOID CASES. THE MODEL IS FILTERED TO SHOW ONLY "PU-621RA" INCIDENTS. THE FINAL RESULT SHOWS 39 INCIDENTS WHERE UPS CAUSED CNS, PU-621RA CAUSED POWER ISSUES. TOTAL NUMBER OF UPS SOLD TILL JAN 22, 2020 IS (B)(4) IN THE US SINCE 2014 (B)(4). ACCORDING TO THE TABLE IN QUALITY COMPLAINT INVESTIGATIONS WORK INSTRUCTION, WITH DOCUMENT ID: SOP06-075, THE RISK PRIORITY OF THE ISSUE IS CATEGORIZED AS: MEDIUM. INVESTIGATION CONCLUSION: ROOT CAUSE OF CNS STARTUP SCREEN STUCK WAS IDENTIFIED TO BE HARD DISK FAILURE AS CNS WAS POWERED BACK ON WITHOUT UPS. HOWEVER, THE ROOT CAUSE OF UPS FAILURE COULD NOT BE IDENTIFIED AS UPS IS OUTSOURCED BY NK. THE POSSIBLE CAUSES OF THE UPS FAILURE ARE LISTED IN ISHIKAWA/ FISHBONE / CAUSE AND EFFECT DIAGRAM DESCRIBED ABOVE. THE WARRANTY OF CNS DEVICE EXPIRED ON 07/30/2019. ACCORDING TO THE TABLE IN QUALITY COMPLAINT INVESTIGATIONS WORK INSTRUCTION, WITH DOCUMENT ID: SOP06-075, THE RISK PRIORITY OF THE ISSUE IS CATEGORIZED AS: MEDIUM. INVESTIGATION CONCLUSION: ROOT CAUSE OF CNS STARTUP SCREEN STUCK WAS IDENTIFIED TO BE HARD DISK FAILURE AS CNS WAS POWERED BACK ON WITHOUT UPS. HOWEVER, THE ROOT CAUSE OF UPS FAILURE COULD NOT BE IDENTIFIED AS UPS IS OUTSOURCED BY NK. THE POSSIBLE CAUSES OF THE UPS FAILURE ARE LISTED IN ISHIKAWA/ FISHBONE / CAUSE AND EFFECT DIAGRAM DESCRIBED ABOVE. THE WARRANTY OF CNS DEVICE EXPIRED ON 07/30/2019. ACCORDING TO THE TABLE IN QUALITY COMPLAINT INVESTIGATIONS WORK INSTRUCTION, WITH DOCUMENT ID: SOP06-075, THE RISK PRIORITY OF THE ISSUE IS CATEGORIZED AS: MEDIUM.
CUSTOMER REPORTED THAT THE UPS FOR THEIR CNS APPEARED TO HAVE FAILED. WHEN THE CNS POWERED BACK ON WITHOUT THE UPS, THE SYSTEM WAS STUCK ON THE LOADING OPERATING SYSTEM SCREEN AND WOULDN'T MOVE PAST THE CNS-6201 SPLASH SCREEN. SERVICE REQUESTED: HARD DRIVE EXCHANGE SERVICE PERFORMED: HARD DRIVE EXCHANGE MISSING INFORMATION: N/A REQUIRED INFORMATION: N/A INVESTIGATION RESULT(S): TECHNICAL SUPPORT ADVISED THE USER THAT THEY WOULD NEED TO TROUBLESHOOT THE HARD DRIVES (HDD) TO DETERMINE IF IT WAS A SINGLE HDD FAILURE OR A SYSTEM IMAGE ISSUE. THE USER REPORTED AFTER REMOVING THE SECONDARY HDD FROM THE BOTTOM PORT THE CNS BOOTED UP FINE. THE FAILED HARD DRIVE WAS SENT IN AND EXCHANGED FOR A NEW ONE. THE DEFECTIVE HARD DRIVE WAS SCRAPPED. THIS UPS IS PROVIDED BY AMETEK POWERVAR, WHICH IS NOT A PART OF NK. PER MANUFACTURER'S MANUAL, THE BATTERIES ARE DESIGNED TO LAST FROM 2-5 YEARS BUT THEIR ACTUAL LIFE SPAN WILL DEPEND ON SEVERAL FACTORS INCLUDING HOW OFTEN POWER OUTAGES OCCUR, HOW LONG POWER OUTAGES LAST, AND THE TEMPERATURE OF THE ENVIRONMENT IN WHICH THE UPS OPERATES. THE UPS IS INTENDED TO BE USED AS A BACK-UP POWER SOURCE IN CASE AC POWER WAS LOST AND IS NOT MEANT TO BE USED AS A STAND-ALONE POWER SUPPLY. POSSIBLE ROOT CAUSES FOR UPS FAILURE ARE EITHER BATTERIES FAILING OR END OF LIFE SPAN DUE TO USE. THE ROOT CAUSE OF THE CNS STARTUP ISSUE WAS FOUND TO BE A DEFECTIVE HDD FROM THE BOTTOM PORT OF THE CNS. REMOVING THE DEFECTIVE HDD RESOLVED THE CNS STARTUP ISSUE. AVAILABLE INFORMATION IN THE COMPLAINT RECORD DOCUMENTS THAT NO HARM WAS REPORTED DUE TO DEVICE MALFUNCTION. THIS COMPLAINT RECORD DOES NOT REQUIRE FURTHER INVESTIGATION.
THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) SHUT DOWN UNEXPECTEDLY DUE TO AN UNINTERRUPTIBLE POWER SUPPLY (UPS) FAILURE.
THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) SHUT DOWN UNEXPECTEDLY DUE TO AN UNINTERRUPTIBLE POWER SUPPLY (UPS) FAILURE.
THE CUSTOMER REMOVED THE DEVICE FROM THE UPS AND TRIED TO POWER IT BACK UP, BUT THE DEVICE WOULD NOT FULLY LOAD THE CNS SOFTWARE. THROUGH TROUBLESHOOTING, IT WAS DISCOVERED THAT ONE OF THE HDDS HAD FAILED. THEY WILL REPLACE THE FAILED HARD DRIVE AND UPS TO RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) SHUT DOWN UNEXPECTEDLY DUE TO AN UNINTERRUPTIBLE POWER SUPPLY (UPS) FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26071 | CNS-6201A | CENTRAL MONITOR SYSTEM | MHX | NIHON KOHDEN CORPORATION | CNS-6201A | NOT APPLICABLE | 04931921114131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |