MAUDE Adverse Event Report: Nihon Kohden Corporation CNS-2101 Central Monitor; Central Monitoring System

Model Number	CNS-2101
Medical Device Problem Codes	Device Alarm System (1012); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that a v-fib alarm from the gz transmitter was not sent to the patient's hx module.He stated the alarm was captured and acknowledged in the sickbay system but was concerned that the cns did not alarm.He requested a log review to confirm whether the alarm was captured at the cns.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: d10 concomitant medical device: the following device was used in conjunction with the cns: gz transmitter: model #:gz-130pa serial #: (b)(6) device manufacturer data: 12/07/2017 unique identifier (udi) #: (b)(4) returned to nihon kohden: na.
Event or Problem Description
The customer reported that a v-fib alarm from the gz transmitter was not sent to the patient's hx module.He stated the alarm was captured and acknowledged in the sickbay system but was concerned that the cns did not alarm.No patient harm was reported.

• Brand Name: CNS-2101 Central Monitor
• 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: 25628011
• Report Number: 8030229-2026-06766
• Device Sequence Number: 9838774
• Product Code: MHX
• UDI-Device Identifier: 04931921017159
• UDI-Public: (01)04931921017159
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K223567
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: CNS-2101
• Device Catalogue Number: CNS-2101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2026
• 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: GZ TRANSMIITER (GZ-130PA)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown