MAUDE Adverse Event Report: Nihon Kohden Corporation Nihon Kohden Life Scope G5 Bedside Monitoring System

Model Number	CU-152R
Medical Device Problem Codes	No Device Output (1435); Device-Device Incompatibility (2919); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that this g5 monitor would not obtain a non-invasive blood pressure (nibp) reading for patients with high blood pressure when this transport monitor was connected.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that this g5 monitor (cu-152ra, sn: (b)(6)) would not obtain a non-invasive blood pressure (nibp) reading for patients with high blood pressure when a transport monitor (bsm-1753a, sn: (b)(6)) was connected.The hose connector had been modified for use with welch allyn cuffs.However, the bme replaced the cuff and hose with known working ones, but the problem persisted.The bme also replaced the bsm-1753 and confirmed the issue occurred intermittently.The initial cuff pressure setting was set at 180 mmhg and was increased to 225 mmhg, but the issue persisted.When the bsm-1753 was removed from the g5 unit, the bsm-1753 obtained a bp reading, even when elevated, within two to three cycles.When the bsm-1753 was connected, the g5 attempted eight cycles and failed.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 g5 monitor: bsm-1700: model #: bsm-1753a.Serial #: (b)(6).Device manufacturer data: 11/08/2024 (nov.) unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.

• Brand Name: Nihon Kohden Life Scope G5 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: 50041802
• Report Number: 8030229-2026-06892
• Device Sequence Number: 10506747
• Product Code: MHX
• UDI-Device Identifier: 04931921002056
• UDI-Public: (01)04931921002056
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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-152R
• Device Catalogue Number: CU-152R
• 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: 06/30/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2024
• 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: Bedside Monitor (BSM-1700).
• Patient Sex: Unknown