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

Model Number	PU-621R
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the central nurse station (cns) display was black while in patient use.The cns tower showed one solid green light and one intermittently flashing green light.Technical support (ts) informed the bme that the unit is end-of-life and suggested the issue might be related to the monitor connection, as the tower had power.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: 12/09/2025 emailed the bme for the information in the ni list above: no reply was received.Attempt # 2: 12/18/2025 emailed the bme for the information in the ni list above: no reply was received.Attempt # 3: 12/30/2025 emailed the bme for the information in the ni list above: no reply was received.
Event or Problem Description
The biomedical engineer (bme) reported that the central nurse station (cns) display was black while in patient use.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the central nurse station (cns) display was black while in patient use.The cns tower showed one solid green light and one intermittently flashing green light.Technical support (ts) informed the bme that the unit is end-of-life and suggested the issue might be related to the monitor connection, as the tower had power.No patient harm was reported.Investigation summary: relevant additional information after complaint intake: further discussion determined the customer was attempting to use an remote network station (rns) as a display and was unaware it was not a standard monitor.Nk tech support clarified that the unit was an rns and recommended testing with a proper display and different cable.The customer agreed to work with it to obtain the correct display and cable.Another attempt for additional information and product return was made on 02/26/2026.Insufficient information / no product returned: multiple attempts were made to collect additional information regarding the complaint.However, there has been no response from the customer.There is not enough information to perform an investigation.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10.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 central nurse station (cns) display was black while in patient use.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: 23933637
• Report Number: 8030229-2025-05964
• Device Sequence Number: 9611234
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: (01)04931921114131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/02/2026

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: 12/05/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.
• Patient Sex: Unknown