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

Model Number	PU-621R
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the central nurse's station (cns) failed and that the raid drive failed.The biomed removed the backup drive for this unit in the past and never replaced it, and they do not have a backup.Not in patient use.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.
Event or Problem Description
The biomedical engineer (bme) reported that the central nurse's station (cns) failed and that the raid drive failed.The biomed removed the backup drive for this unit in the past and never replaced it, and they do not have a backup.Not in patient use.
Event or Problem Description
The biomedical engineer (bme) reported that the central nurse's station (cns) failed and that the raid drive failed.The biomed removed the backup drive for this unit in the past and never replaced it, and they do not have a backup.Not in patient use.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the central nurse's station (cns) failed and that the raid drive failed.The biomed removed the backup drive for this unit in the past and never replaced it, and they do not have a backup.Not in patient use.Investigation conclusion: the customer reported that an icu cns-6201 experienced a raid failure.Review determined that the backup drive had previously been removed by the facility and was never replaced, leaving the system without redundancy.The unit was not in patient use at the time of the report.Nk tech support advised that the cns-6201 / pu-621ra platform is end of life and confirmed that replacing the system with a cns-2101a was acceptable.The customer proceeded with replacement using a cns-2101a.No patient harm or adverse events were reported.As the reported device was not returned for evaluation, the reported issue could not be duplicated nor confirmed.As such, root cause cannot be determined.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.

• 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: 23538407
• Report Number: 8030229-2025-05792
• Device Sequence Number: 10124053
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: (01)04931921114131
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 02/05/2026

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: 11/03/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2013
• 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