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); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The nk employee (cas manager) reported on behalf of the anesthesiologist that the nibp function on the g7 monitor was only intermittently taking interval readings during a case, requiring manual depressing of the start/stop button to initiate the bp measurement.No patient harm was reported.
Additional Manufacturer Narrative
The nk employee (cas manager) reported on behalf of the anesthesiologist that the nibp function on the g7 monitor was only intermittently taking interval readings during a case, requiring manual depressing of the start/stop button to initiate the bp measurement.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 g7 model #: bsm-1733a; serial #: (b)(6); device manufacturer date: 11/19/2024; unique identifier (udi) #: (b)(4); returned to nihon kohden: na.

• 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: 25680794
• Report Number: 8030229-2026-06796
• Device Sequence Number: 9709309
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: CU-172R
• Device Catalogue Number: CU-172R
• 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: 06/12/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INPUT UNIT (BSM-1733A)
• Patient Sex: Unknown