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

Model Number	CNS-2101
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (biomed) reported that the zm transmitter stopped giving ecg heart rate (hr) readings while in patient use.He tried using different leads, but the issue persisted.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.
Event or Problem Description
The biomedical engineer (biomed) reported that the zm transmitter stopped giving ecg heart rate (hr) readings while in patient use.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: 25552925
• Report Number: 8030229-2026-06749
• Device Sequence Number: 16142971
• Product Code: MHX
• UDI-Device Identifier: 04931921017159
• UDI-Public: (01)04931921017159
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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?: Yes
• Date Returned to Manufacturer: 06/23/2026
• 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: 05/26/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2017
• 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: NA.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown