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

Model Number	PU-621R
Medical Device Problem Codes	Unable to Obtain Readings (1516); 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	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nurse manager reported that four zm transmitters were not displaying the heart rate (hr) at the central nurse's station (cns).They were functioning normally for approximately 45 minutes prior to the call.The nurses reported seeing a "check electrodes" error message on three of the devices.The problem initially started with two teles and had since expanded to four.They tried removing and re-inserting the batteries and swapped the ecg cables, but the issue persisted.They were using a mixture of nk and non-nk accessories.No patient harm was reported.Each of the four zm transmitters were reported respectively in the following tickets: (b)(4).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: d10 concomitant medical device: the following devices were used in conjunction with the cns: zm transmitter: model #: zm-530pa.Serial #: (b)(6).Device manufacturer data: 11/10/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Zm transmitter: model #: zm-530pa.Serial #: (b)(6).Device manufacturer data: 11/10/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Zm transmitter: model #: zm-530pa.Serial #: (b)(6).Device manufacturer data: 11/10/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Zm transmitter: model #: zm-530pa.Serial #: (b)(6).Device manufacturer data: 11/10/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.
Event or Problem Description
The nurse manager reported that four zm transmitters were not displaying the heart rate (hr) at the central nurse's station (cns).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: 24279873
• Report Number: 8030229-2026-06190
• Device Sequence Number: 15533437
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: 01/16/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2015
• 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: 4 ZM TRANSMITTERS (ZM-530PA)
• Patient Sex: Unknown