NI
Report
- Report Number
- 8030229-2022-02428
- Event Type
- Malfunction
- Date Received
- February 3, 2022
- Date of Event
- January 4, 2022
- Report Date
- April 19, 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
- VA, US
- Reporter Occupation
- 003
Narratives
THE CUSTOMER IT REPORTED THAT THE GZ TELEMETRY TRANSMITTERS WERE UNABLE TO CONNECT AND BE MONITORED BY THE CENTRAL NURSE'S STATION (CNS) AFTER THEY DID A MONTHLY REBOOT ON THE SERVER. THEY STATED THAT THEY FORGOT TO PUT THE GZS IN LOCAL MODE AND BECAUSE OF THIS THE GZS ARE NOT CONNECTING AFTER THE SERVER CAME BACK UP. NIHON KOHDEN COMPUTER INFORMATION TECHNOLOGY SYSTEMS SUPPORT (CITS) LOGGED INTO THE SERVER AND FOUND THAT THE UNIFIED GATEWAY (UG) SERVICE WAS NOT RUNNING. THEY STARTED THE SERVICE, AND THE CUSTOMER STATED THAT AFTER THE UG SERVICE WAS STARTED, THEY STARTED TO SEE THE TELEMETRY BEDS COME BACK ONLINE. 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. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE BEING USED IN CONJUNCTION WITH THE CNS. TELEMETRY TRANSMITTER: MODEL: GZ-130PA. SN: (B)(4).
DETAILS OF COMPLAINT: THE CUSTOMER'S IT DEPARTMENT REPORTED THAT THE GZ TELEMETRY TRANSMITTERS WERE UNABLE TO CONNECT AND BE MONITORED BY THE CENTRAL NURSE'S STATION (CNS) AFTER A MONTHLY REBOOT OF THE SERVER. THEY HAD FORGOTTEN TO PUT THE GZ TRANSMITTERS IN LOCAL MODE, WHICH CAUSED THE ISSUE. NIHON KOHDEN COMPUTER INFORMATION TECHNOLOGY SYSTEMS SUPPORT (CITS) LOGGED INTO THE SERVER AND FOUND THAT THE UNIFIED GATEWAY (UG) SERVICE WAS NOT RUNNING. THEY STARTED THE SERVICE, WHICH RESOLVED THE ISSUE. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE CAUSE FOR THE COMMUNICATION ISSUE IS TYPICALLY DUE TO BEDSIDE, TRANSMITTER OR ORG RECEIVER BEING DISCONNECTED FROM THE NETWORK. THE ROOT CAUSE OF GZ TRANSMITTERS NOT CONNECTING IS RELATED TO USER EDUCATION. THE USER HAD PERFORMED A SERVER REBOOT BUT DID NOT VERIFY THAT THE UNIFIED GATEWAY SERVICE WAS STARTED ON THE SERVER. ONCE THE SERVICE WAS STARTED, THE GZ TRANSMITTERS WERE ABLE TO CONNECT. THERE IS NO EVIDENCE OF AN NK DEVICE MALFUNCTION. THE USER WAS EDUCATED ON WHAT ACTIONS TO TAKE AND WHAT TO LOOK OUT FOR AFTER THEY PERFORM A SERVER REBOOT. A COMPLAINT HISTORY REVIEW OF THE GZ-130PA SERIAL NUMBER (B)(6) REVEALS NO RECURRENCE OF THE REPORTED ISSUE.
THE CUSTOMER IT REPORTED THAT THE GZ TELEMETRY TRANSMITTERS WERE UNABLE TO CONNECT AND BE MONITORED BY THE CENTRAL NURSE'S STATION (CNS) AFTER THEY DID A MONTHLY REBOOT ON THE SERVER. THEY STATED THAT THEY FORGOT TO PUT THE GZS IN LOCAL MODE AND BECAUSE OF THIS THE GZS ARE NOT CONNECTING AFTER THE SERVER CAME BACK UP. NIHON KOHDEN COMPUTER INFORMATION TECHNOLOGY SYSTEMS SUPPORT (CITS) LOGGED INTO THE SERVER AND FOUND THAT THE UNIFIED GATEWAY (UG) SERVICE WAS NOT RUNNING. THEY STARTED THE SERVICE, AND THE CUSTOMER STATED THAT AFTER THE UG SERVICE WAS STARTED, THEY STARTED TO SEE THE TELEMETRY BEDS COME BACK ONLINE. NO PATIENT HARM WAS REPORTED.
THE CUSTOMER'S IT DEPARTMENT REPORTED THAT THE GZ TELEMETRY TRANSMITTERS WERE UNABLE TO CONNECT AND BE MONITORED BY THE CENTRAL NURSE'S STATION (CNS) AFTER A MONTHLY REBOOT OF THE SERVER. THEY HAD FORGOTTEN TO PUT THE GZ TRANSMITTERS IN LOCAL MODE, WHICH CAUSED THE ISSUE. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 705816 | NI | CENTRAL MONITOR STATION | MHX | NIHON KOHDEN CORPORATION | NI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | GZ-130PA SN (B)(6)| TRANSMITTERS GZ-130PA |