MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NIHON KOHDEN LIFE SCOPE G7 BEDSIDE MONITORING SYSTEM

Model Number	CU-172R
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Output Problem (3005); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the g7 bedside monitor had a black screen.Tech support (ts) asked her to reseat the power cord because a loose cable could cause the monitor to shut off however this did not resolve the issue.When unplugging the power cord, the alarm went off, so the device definitely had power, but the screen was black.The issue has been resolved by removing the batteries and fully shutting the monitor down.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: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10: concomitant medical device.Attempt #1 01/15/2025 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they did not provide the additional device information as requested.
Event or Problem Description
The customer reported that the g7 bedside monitor had a black screen.Tech support (ts) asked her to reseat the power cord because a loose cable could cause the monitor to shut off however this did not resolve the issue.When unplugging the power cord, the alarm went off, so the device definitely had power, but the screen was black.The issue has been resolved by removing the batteries and fully shutting the monitor down.No patient harm was reported.
Event or Problem Description
The customer reported that the g7 bedside monitor had a black screen.Tech support (ts) asked her to reseat the power cord because a loose cable could cause the monitor to shut off however this did not resolve the issue.When unplugging the power cord, the alarm went off, so the device definitely had power, but the screen was black.The issue has been resolved by removing the batteries and fully shutting the monitor down.No patient harm was reported.
Additional Manufacturer Narrative
The customer reported that the g7 bedside monitor had a black screen.Tech support (ts) asked her to reseat the power cord because a loose cable could cause the monitor to shut off however this did not resolve the issue.When unplugging the power cord, the alarm went off, so the device definitely had power, but the screen was black.The issue has been resolved by removing the batteries and fully shutting the monitor down.No patient harm was reported.Investigation conclusion: insufficient information / no product returned multiple attempts were made to collect additional information regarding the complaint.However, there has been no response from the customer.There is not enough information to perform an investigation.Additional device information: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device.Attempt #1: 01/15/2025 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they did not provide the additional device information as requested.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: 24141287
• Report Number: 8030229-2026-06094
• Device Sequence Number: 9502044
• Product Code: MHX
• UDI-Device Identifier: 04931921004517
• UDI-Public: (01)04931921004517
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2022
• 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