MAUDE Adverse Event Report: Nihon Kohden Corporation PU-621R; Central Monitoring System

Model Number	PU-621R
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that this central nurse's station (cns) is not showing a pap waveform under individual waveforms and the pap option is not showing up at all under full disclosure for displayed wave setting or stored wave settings.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that this central nurse's station (cns) is not showing a pap waveform under individual waveforms and the pap option is not showing up at all under full disclosure for displayed wave setting or stored wave settings.The customer is also not seeing it as an option under record wave selection.The bedside can still see the pap waveform and in fd data on the bed it shows up.The customer can still the pap numerical data under individual waveforms, but not the waveform.Technical support (ts) had the customer reboot the cns; however, the issue remained.Ts had the customer copy the bed settings on the cns from a working bed to this one and this yielded no change.Ts advised the customer to reboot the bedside and if the issue persists to try un-monitor and re-monitor the bed from the cns.The customer stated they'll wait after discharging the patient to see if issue persists as they don't need this parameter urgently.There was no patient injury 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: (b)(6) 2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.

• 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: 24877648
• Report Number: 8030229-2026-06498
• Device Sequence Number: 18412469
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: (01)04931921114131
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/29/2026

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 07/29/2026
• 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.
• Patient Sex: Unknown