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

Model Number	CU-172R
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the nibp readings were inconsistent on this g7 bedside monitor.This unit gave several readings that were all over the place.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the nibp readings were inconsistent on this g7 bedside monitor.This unit gave several readings that were all over the place.No patient harm was reported.Investigation conclusion: logs were submitted, and an investigation was requested from nkc.Log review at nka did not identify abnormal device function.From 7:50:12 to 8:05:02, there were six "weak pulse" technical messages indicating the patient's pulse was too small for measurement, the cuff was wrapped too loosely, or the cuff size was inappropriate.In response to this error message, it is recommended to adjust cuff placement.If the error message persists, it may be necessary to measure by palpation or with the invasive blood pressure method.From reporting, the customer facility was using medline cuffs, and the relay air hose had been modified.The measurement consisted of non-validated, facility-modified components and third-party accessories, which falls outside of the verified and quality-assured configurations.Nkc was unable to provide root cause analysis, technical comments, or performance guarantees for nibp measurements conducted under non-validated configurations.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h11 additional manufacturer narrative.

• 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: 50410357
• Report Number: 8030229-2026-06942
• Device Sequence Number: 10444347
• 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): 10/02/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 10/02/2026
• 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
• Patient Sex: Unknown