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

Model Number	PU-621R
Medical Device Problem Codes	Application Program Problem (2880); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the central nurse's station (cns) has dual displays, and both screens are black with one screen showing "operating system setup".She said it has been stuck on this screen for quite some time, and they have already tried force rebooting without success.No patient harm was reported.
Additional Manufacturer Narrative
The customer reported that the central nurse's station (cns) has dual displays, and both screens are black with one screen showing "operating system setup".She said it has been stuck on this screen for quite some time, and they have already tried force rebooting without success.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.Additional device information: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device.Attempt #1, 12/18/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2, 12/22/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3, 12/29/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.
Additional Manufacturer Narrative
The customer reported that the central nurse's station (cns) has dual displays, and both screens are black with one screen showing "operating system setup".She said it has been stuck on this screen for quite some time, and they have already tried force rebooting without success.No patient harm was reported.Investigation conclusion: 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.Additional device information: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10.Concomitant medical device.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 customer reported that the central nurse's station (cns) has dual displays, and both screens are black with one screen showing "operating system setup".She said it has been stuck on this screen for quite some time, and they have already tried force rebooting without success.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: 24015719
• Report Number: 8030229-2026-05995
• Device Sequence Number: 12996791
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: (01)04931921114131
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 12/16/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2017
• 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