MAUDE Adverse Event Report: Nihon Kohden Corporation PU-681RA; Central Monitoring System

Model Number	PU-681RA
Medical Device Problem Codes	Application Program Problem (2880); Communication or Transmission Problem (2896); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the central nurse's station (cns) was originally displaying comm loss on all the tiles.He disconnected and reconnected the ethernet cable but that did not resolve the issue, so he rebooted the cns.After rebooting the cns, it began boot looping.He removed the cns from service and replaced it with a spare unit.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the central nurse's station (cns) was originally displaying comm loss on all the tiles.He disconnected and reconnected the ethernet cable but that did not resolve the issue, so he rebooted the cns.After rebooting the cns, it began boot looping.He removed the cns from service and replaced it with a spare unit.No patient harm was reported.(b)(6) continues to investigate the reported event.(b)(6) will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

• Brand Name: PU-681RA
• 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: 50755105
• Report Number: 8030229-2026-07048
• Device Sequence Number: 9631530
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: (01)04931921131640
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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-681RA
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/14/2026
• 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