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

Model Number	PU-621R
Medical Device Problem Codes	No Audible Prompt/Feedback (2282); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the spo2 alarm was disconnected and the unit did not alarm or escalate to critical after 3 minutes.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that the spo2 alarm was disconnected and the unit did not alarm or escalate to critical after 3 minutes.According to the customer, the unit displayed the spo2 message disconnected and displayed a yellow alarm light.The clinical specialist troubleshot the issue and could not generate an escalation, the monitor is not responding for the escalation.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: 01/08/2026, emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 01/16/2026, i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.Attempt # 3: 01/20/2026, i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.
Event or Problem Description
The customer reported that the spo2 alarm was disconnected and the unit did not alarm or escalate to critical after 3 minutes.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the spo2 alarm was disconnected and the unit did not alarm or escalate to critical after 3 minutes.According to the customer, the unit displayed the spo2 message disconnected and displayed a yellow alarm light.The clinical specialist troubleshot the issue and could not generate an escalation, the monitor is not responding for the escalation.There was no patient injury reported.Investigation summary: the device with the reported issue was not returned for evaluation; therefore, a root cause could not be determined.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 01/08/2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 01/16/2026 i called lara to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for lara to call me back with this information.Attempt # 3: 01/20/2026 i called lara to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for lara to call me back with this information.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type?.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: 24115564
• Report Number: 8030229-2026-06058
• Device Sequence Number: 9515609
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: (01)04931921114131
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 04/07/2026

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: 01/02/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2011
• 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