MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION PU-621R; CENTRAL MONITORING SYSTEM

Model Number	PU-621R
Medical Device Problem Codes	Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse reported that the cns application on the central nurse's station (cns) spontaneously reboot on its own and would not come back up.When trying to reboot the cns, she received some kind of network error but could not recall what it said.No patient harm was reported.
Additional Manufacturer Narrative
The nurse reported that the cns application on the central nurse's station (cns) spontaneously reboot on its own and would not come back up.When trying to reboot the cns, she received some kind of network error but could not recall what it said.Technical support (ts) had her try rebooting the cns one more time and it came up to the monitoring software with no issue.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 field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: (b)(6) 2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2025 emailed the customer via microsoft outlook for the information in the ni list above: the customer replied, stating they were unable to provide the requested information.
Additional Manufacturer Narrative
Details of complaint: the nurse reported that the central nurse's station (cns) that was monitoring their tele devices, spontaneously shut down and would not come back up.Technical support (ts) verified that all cables were fully plugged into the cns and a working outlet.It was noted that the user had a space heater under the desk near the cns, so heat could be a factor.There were no lights on the front of the cns and pressing the power button resulted in no lights and no sounds.No patient harm was reported.Investigation summary: nk tech support guided the customer through an additional power cycle of the cns.Following a graceful reboot, the system successfully launched the monitoring software and returned to normal operation.The reported error message was no longer present and could not be reproduced.The root cause could not be determined.Nihon kohden will continue to trend and monitor.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 10/27/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 11/05/2025 emailed the customer via microsoft outlook for the information in the ni list above: the customer replied, stating they were unable to provide the requested information.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.H11 additional manufacturer narrative.
Event or Problem Description
The nurse reported that the cns application on the central nurse's station (cns) spontaneously rebooted on its own and would not come back up.When trying to reboot the cns, she received some kind of network error but could not recall what it said.No patient harm was reported.

• Brand Name: PU-621R
• Common Device Name: CENTRAL MONITORING SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 23610794
• Report Number: 8030229-2025-05841
• Device Sequence Number: 9821174
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: (01)04931921114131
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K102376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PU-621R
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown