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

Model Number	PU-681RA
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the central nurse's station (cns) displayed a windows blue screen with machine_check_exception error.The unit was powered off / on.It booted for approximately 20 seconds, began loading windows, then displayed a second blue screen with a clock_watchdog_timeout error.They also noted that the fan at the bottom/rear of the tower did not appear to be spinning.Symptoms appear consistent with a hardware issue.Tech support (ts) recommended sending the unit to the repair center for evaluation.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the central nurse's station (cns) displayed a windows blue screen with machine_check_exception error.The unit was powered off / on.It booted for approximately 20 seconds, began loading windows, then displayed a second blue screen with a clock_watchdog_timeout error.They also noted that the fan at the bottom/rear of the tower did not appear to be spinning.Symptoms appear consistent with a hardware issue.Tech support (ts) recommended sending the unit to the repair center for evaluation.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.

• 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: 50839478
• Report Number: 8030229-2026-07125
• Device Sequence Number: 9957527
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: (01)04931921131640
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/21/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2021
• 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