MAUDE Adverse Event Report: Nihon Kohden Corporation Nihon Kohden Life Scope G7 Bedside Monitoring System

Model Number	CU-172R
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	05/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nk's employee (tsam) reported on behalf of the biomedical engineer (biomed) that the g7 monitor was giving erratic ecg readings, the nibp function would not always take a pressure, and the ibp values were not transferring to epic.They also reported that the alarms would go off very easily.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.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 05/18/2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 05/20/2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 3: 06/08/2026 emailed the customer via microsoft outlook for the information in the ni list above: the customer replied, stating that the requested information cannot be provided.
Event or Problem Description
The nk's employee (tsam) reported on behalf of the biomedical engineer (biomed) that the g7 monitor was giving erratic ecg readings, the nibp function would not always take a pressure, and the ibp values were not transferring to epic.They also reported that the alarms would go off very easily.No patient harm was reported.

• Brand Name: Nihon Kohden Life Scope G7 Bedside Monitoring System
• Common Device Name: Bedside Monitor
• 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: 25437992
• Report Number: 8030229-2026-06710
• Device Sequence Number: 13309274
• Product Code: MHX
• UDI-Device Identifier: 04931921004517
• UDI-Public: (01)04931921004517
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203435
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2026

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: CU-172R
• Device Catalogue Number: CU-172R
• Was Device Available for Evaluation?: No
• 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: 05/15/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2025
• 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