NI
Report
- Report Number
- 8030229-2021-00388
- Event Type
- Malfunction
- Date Received
- July 3, 2021
- Date of Event
- June 3, 2021
- Report Date
- February 28, 2023
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- MHX
- PMA / PMN Number
- NI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE BIOMEDICAL ENGINEER REPORTED THAT THERE WAS A POWER OUTAGE, AND IT TOOK DOWN THE HOSPITAL NETWORK. THE CENTRAL NURSE'S STATION (CNS) AND REMOTE NETWORK STATION (RNS) WENT DOWN. AFTER THE POWER WAS RESTORED THE CNS WAS UP AND RUNNING WITHOUT ISSUES, BUT THE RNS ARE NOW IN COMM LOSS. THE BIOMED DID NOT HAVE SERVER ACCESS TO START UP THE APPLICATION HIMSELF. HOST 1000 APPLICATION NEEDED TO BE STARTED AFTER THE POWER OUTAGE. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) SPOKE WITH BOTH LGH AND ACADIA AND BOTH CONFIRMED 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.
DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER REPORTED THAT THERE WAS A POWER OUTAGE, AND IT TOOK DOWN THE HOSPITAL'S NETWORK. THE CENTRAL NURSE'S STATION (CNS) AND REMOTE NETWORK STATION (RNS) WENT DOWN. THE HOST 1000 APPLICATION NEEDED TO BE STARTED AFTER THE POWER OUTAGE. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: THE POWER OUTAGE CAUSED AN UNGRACEFUL EXIT TO THE SERVER, MONITORING DEVICES, AND SOFTWARE. THE ROOT CAUSE IS DETERMINED TO BE THE FACILITY'S NETWORK OUTAGE (ENVIRONMENT). THE HOST 1000 APPLICATION NEEDED TO BE REBOOTED AFTER POWER OUTAGE. POWER RESTORATION CORRECTED THE ISSUE. THE POSSIBLE CAUSES OF HL7 SERVER ISSUES ARE LIMITED TO CUSTOMER NETWORKS/SERVERS AS WELL AS CUSTOMER USER SPECIFICATIONS SUCH AS DATA QUEUING, UNGRACEFUL EXITS, INCORRECT CUSTOMER FLOWS, PERMISSION ISSUES, ETC. THESE ISSUES RANGE FROM INTERNAL NETWORK SETTINGS OF THE CUSTOMER TO POWER OUTAGES, POWER SURGES, SYSTEM CRASHES AND UPDATING ERRORS, WHICH ARE FACTORS OUTSIDE NK CONTROL. THESE ARE NOT RELATED TO MALFUNCTIONING OR DEVIATION FROM PERFORMANCE OF NK DEVICES. CNS-6201 OPERATOR'S MANUAL ADVISES THE CUSTOMER THAT THE MONITOR COMMUNICATES WITH THE OTHER SYSTEMS USING THE HL7 SERVER VIA THE HOSPITAL NETWORK. ISSUES WITH COMMUNICATION DISRUPTION BETWEEN THE CNS AND THE OTHER DEVICES COULD BE IS ATTRIBUTED TO THE CUSTOMER NETWORK MALFUNCTION. THESE ARE NOT RELATED TO MALFUNCTIONS OR DEVIATIONS FROM PERFORMANCE OF NK DEVICES.
DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER REPORTED THAT THERE WAS A POWER OUTAGE, AND IT TOOK DOWN THE HOSPITAL'S NETWORK. THE CENTRAL NURSE'S STATION (CNS) AND REMOTE NETWORK STATION (RNS) WENT DOWN. THE HOST 1000 APPLICATION NEEDED TO BE STARTED AFTER THE POWER OUTAGE. NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: THE POWER OUTAGE CAUSED AN UNGRACEFUL EXIT TO THE SERVER, MONITORING DEVICES, AND SOFTWARE. THE ROOT CAUSE IS DETERMINED TO BE THE FACILITY'S NETWORK OUTAGE (ENVIRONMENT). THE HOST 1000 APPLICATION NEEDED TO BE REBOOTED AFTER POWER OUTAGE. POWER RESTORATION CORRECTED THE ISSUE.
THE BIOMEDICAL ENGINEER REPORTED THAT THERE WAS A POWER OUTAGE, AND IT TOOK DOWN THE HOSPITAL NETWORK. THE CENTRAL NURSE'S STATION (CNS) AND REMOTE NETWORK STATION (RNS) WENT DOWN. AFTER THE POWER WAS RESTORED THE CNS WAS UP AND RUNNING WITHOUT ISSUES, BUT THE RNS ARE NOW IN COMM LOSS. THE BIOMED DID NOT HAVE SERVER ACCESS TO START UP THE APPLICATION HIMSELF. HOST 1000 APPLICATION NEEDED TO BE STARTED AFTER THE POWER OUTAGE. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) SPOKE WITH BOTH LGH AND ACADIA AND BOTH CONFIRMED THE ISSUE WAS RESOLVED. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER REPORTED THAT THERE WAS A POWER OUTAGE, AND IT TOOK DOWN THE HOSPITAL NETWORK. THE CENTRAL NURSE'S STATION (CNS) AND REMOTE NETWORK STATION (RNS) WENT DOWN. AFTER THE POWER WAS RESTORED THE CNS WAS UP AND RUNNING WITHOUT ISSUES, BUT THE RNS ARE NOW IN COMM LOSS. THE BIOMED DID NOT HAVE SERVER ACCESS TO START UP THE APPLICATION HIMSELF. HOST 1000 APPLICATION NEEDED TO BE STARTED AFTER THE POWER OUTAGE. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) SPOKE WITH BOTH LGH AND ACADIA AND BOTH CONFIRMED THE ISSUE WAS RESOLVED. NO PATIENT HARM WAS REPORTED.
THE BIOMEDICAL ENGINEER REPORTED THAT THERE WAS A POWER OUTAGE, AND IT TOOK DOWN THE HOSPITAL NETWORK. THE CENTRAL NURSE'S STATION (CNS) AND REMOTE NETWORK STATION (RNS) WENT DOWN. AFTER THE POWER WAS RESTORED THE CNS WAS UP AND RUNNING WITHOUT ISSUES, BUT THE RNS ARE NOW IN COMM LOSS. THE BIOMED DID NOT HAVE SERVER ACCESS TO START UP THE APPLICATION HIMSELF. HOST 1000 APPLICATION NEEDED TO BE STARTED AFTER THE POWER OUTAGE. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) SPOKE WITH BOTH LGH AND ACADIA AND BOTH CONFIRMED THE ISSUE WAS RESOLVED. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1010101 | NI | CENTRAL MONITOR STATION | MHX | NIHON KOHDEN CORPORATION | NI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |