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

Model Number	PU-621R
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a time issue on this central nurse's station (cns).According to the customer, they tried to adjust the time; however, it reverts to what it previously was.The customer also mentioned that the rhythm is not reading correctly on this cns.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported a time issue on this central nurse's station (cns).According to the customer, they tried to adjust the time; however, it reverts to what it previously was.The customer also mentioned that the rhythm is not reading correctly on this cns.Technical support (ts) informed the customer that for the time sync issue, they need to locate the cns with the lowest ip and try changing the time on that cns.For the rhythm issue, ts informed the customer that this unit is at the end of service (eos) and all he could suggest was rebooting the devices and possibly stop and restart monitoring the room.Ts also informed the customer that they can send in the unit to have the hdds replaced; however, there's no guarantee that the issue will be resolved.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.
Additional Manufacturer Narrative
Details of complaint: the customer reported a time issue on this central nurse's station (cns).According to the customer, they tried to adjust the time; however, it reverts to what it previously was.The customer also mentioned that the rhythm is not reading correctly on this cns.Technical support (ts) informed the customer that for the time sync issue, they need to locate the cns with the lowest ip and try changing the time on that cns.For the rhythm issue, ts informed the customer that this unit is at the end of service (eos) and all he could suggest was rebooting the devices and possibly stop and restart monitoring the room.Ts also informed the customer that they can send in the unit to have the hdds replaced; however, there's no guarantee that the issue will be resolved.There was no patient injury reported.Investigation summary: the customer reported two issues on a (b)(6): the system time was reverting after manual adjustment following the daylight saving time change, and the rhythm was not displaying correctly for one room despite displaying correctly on the bedside monitor and telemetry transmitter.Nk tech support advised the customer to locate the cns with the lowest ip address and adjust the time from there, and provided admin credentials to allow access to windows settings.Regarding the rhythm display issue, nk tech support advised rebooting the devices and stopping and restarting monitoring for the affected room.The customer was informed that the unit was end of life and end of support, and confirmed no further assistance was needed.Root cause: could not be determined.No further investigation is required.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 03/24/2026 i called chance for information on how the rhythm was not being read correctly.Was the rhythm high/low? i also asked for model and serial numbers of any devices the reported device was connected or related to.A message was left for chance to call me back with this information.Attempt # 2: 03/26/2026 i called chance for information on how the rhythm was not being read correctly.Was the rhythm high/low? i also asked for model and serial numbers of any devices the reported device was connected or related to.A message was left for chance to call me back with this information.Attempt # 3: 03/31/2026 i called chance for information on how the rhythm was not being read correctly.Was the rhythm high/low? i also asked for model and serial numbers of any devices the reported device was connected or related to.A message was left for chance 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? h6 event problem and evaluation codes.H11 additional manufacturer narrative.
Event or Problem Description
The customer reported a time issue on this central nurse's station (cns).According to the customer, they tried to adjust the time; however, it reverts to what it previously was.The customer also mentioned that the rhythm is not reading correctly on this cns.There was no patient injury 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: 24839845
• Report Number: 8030229-2026-06372
• Device Sequence Number: 9594067
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: (01)04931921114131
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/29/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2014
• 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