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

Model Number	PU-621R
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the secondary display on this central nurse station (cns) was blank at bottom of the screen, but the alarm indicator was working.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the secondary display on this central nurse station (cns) was blank at bottom of the screen, but the alarm indicator was working.Technical support (ts) informed the customer that this unit was end of life/service (eol/eos) and options for support were limited.Troubleshooting with ts identified that the power supply was the failure point and advised replacing it or upgrading to new cns with new displays.Ts informed biomed that nk no longer sells the power supply for this display.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 was made, but not provided: d10 attempt # 1: (b)(6) 2025 emailed the bme for the information in the ni list above: the bme replied "unknown.".
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the secondary display on this central nurse station (cns) was blank at bottom of the screen, but the alarm indicator was working.Technical support (ts) informed the customer that this unit was end of life/service (eol/eos) and options for support were limited.Troubleshooting with ts identified that the power supply was the failure point and advised replacing it or upgrading to new cns with new displays.Ts informed biomed that nk no longer sells the power supply for this display.No patient harm was reported.Investigation summary: nk tech support assisted the customer with basic verification of power connections.When the power supply from a known-working display was connected, the non-functional secondary display powered on and operated normally.Electrical testing confirmed ac power was present at the outlet, isolating the failure to the secondary display power supply.The root cause was determined to be a failed power supply associated with an end-of-life/end-of-support component.Replacement through the manufacturer was not available, and the customer was advised to seek a third-party replacement or consider upgrading to a newer system.No further investigation is required.The following field contains no information (ni), as attempts to obtain the information was made, but not provided: d10 attempt # 1: 10/08/2025 emailed the bme for the information in the ni list above: the bme replied "unknown." 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 biomedical engineer (bme) reported that the secondary display on this central nurse station (cns) was blank at bottom of the screen, but the alarm indicator was working.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: 23408137
• Report Number: 8030229-2025-05668
• Device Sequence Number: 18408633
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: (01)04931921114131
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 01/19/2026

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: 10/02/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2017
• 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