MAUDE Adverse Event Report: Nihon Kohden Corporation Life Scope G9; Bedside Monitor

Model Number	CU-192R
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the main display is blacked out but it will respond to touch on the g9 bedside monitor during the boot-up, they can see the values, but once it fully boots up, the display goes black.They rebooted 3 times, and the issue repeats.They swapped the cables and the issue repeats.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the main display is blacked out but it will respond to touch on the g9 bedside monitor during the boot-up, they can see the values, but once it fully boots up, the display goes black.They rebooted 3 times, and the issue repeats.They swapped the cables and the issue repeats.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 bedside monitor: model: bsm-1753a.Sn: (b)(6).
Event or Problem Description
The biomedical engineer (bme) reported that the main display is blacked out but it will respond to touch on the g9 bedside monitor during the boot-up, they can see the values, but once it fully boots up, the display goes black.They rebooted 3 times, and the issue repeats.They swapped the cables and the issue repeats.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the main display is blacked out but it will respond to touch on the g9 bedside monitor during the boot-up, they can see the values, but once it fully boots up, the display goes black.They rebooted 3 times, and the issue repeats.They swapped the cables and the issue repeats.No patient harm was reported.Investigation conclusion: root cause summary/results: we confirmed the reported issue stemmed from wear and tear damage over time (explained further below).In this case, the device was initially installed at the facility on (b)(6)2021, indicating it has aged approximately five years.Aging systems and their components/hardware (including display screens/touchscreens) are susceptible to wear and tear damage over time from user errors (such as mishandling, customer abuse, droppage, improper storage/overheating resulting in screen lamination damage/touchpoint damage, improper cleaning resulting in damage to the screen), frequency of use and normal aging and degradation.Resolution notes: our nk ts tech provided education and ts to the customer as needed.We shipped a replacement device, (cu-192ra serial number (b)(6), with new battery (b)(6) sn:(b)(6), configured as requested), to resolve the issue.Since resolution, no further issues related to this incident have been reported to date.Additional device information: d10: concomitant medical device.Bedside monitor: model: bsm-1753a.Sn: (b)(6).Additional information: b4 date of this report.D9 device available for evaluation.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type?.H3 device evaluated by manufacturer.H6 event problem and evaluation codes.H11 additional manufacturer narrative.

• Brand Name: Life Scope G9
• 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: 24933340
• Report Number: 8030229-2026-06487
• Device Sequence Number: 20172727
• Product Code: MHX
• UDI-Device Identifier: 04931921112168
• UDI-Public: (01)04931921112168
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K213316
• 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): 07/31/2026

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-192R
• Device Catalogue Number: CU-192RA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/16/2026
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• 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: BSM-1753A SN (b)(6)
• Patient Sex: Unknown