MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NIHON KOHDEN LIFE SCOPE G5 BEDSIDE MONITORING SYSTEM

Model Number	CU-152R
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nk employee, on behalf of the biomedical engineer (bme) reported that the etco2 waveform displayed what they called "tiny spikes" on the g9 monitor.Every room displayed the same spikes.The spikes did not display on the draeger monitor for the anesthesia carts.Although the values of the peaks were matching and were sent to the emr normally, the waveforms made it seem like there was a "0" between each peak.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.
Event or Problem Description
The nk employee, on behalf of the biomedical engineer (bme) reported that the etco2 waveform displayed what they called "tiny spikes" on the g9 monitor.Every room displayed the same spikes.The spikes did not display on the draeger monitor for the anesthesia carts.Although the values of the peaks were matching and were sent to the emr normally, the waveforms made it seem like there was a "0" between each peak.No patient harm was reported.
Event or Problem Description
The nk employee, on behalf of the biomedical engineer (bme) reported that the etco2 waveform displayed what they called "tiny spikes" on the g5 monitor.Every room displayed the same spikes.The spikes did not display on the accompanying draeger monitor for the anesthesia carts.Although the values of the peaks were matching and were sent to the emr correctly, the waveforms made it appear there was a "0" between each peak.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the nk employee reported that the etco2 waveform displayed what they called "tiny spikes" on the g5 monitor.Every room displayed the same spikes.The spikes did not display on the accompanying draeger monitor for the anesthesia carts.Although the values of the peaks were matching and were sent to the emr correctly, the waveforms made it appear there was a "0" between each peak.No patient harm was reported.Investigation summary: the logs were collected from the impacted nihon kohden devices and sent to nihon kohden corporation (nkc) for review.Nkc's investigation found that the cause of the issue was determined to be a software bug related to demo mode.In all logs submitted, they confirmed the operation of the device in demo mode, followed by continued use without powering down.The recommended workaround is to restart the monitor before using it after exiting demo mode.Nk will continue to trend and monitor.Additional information: b4 date of this report.E3 occupation.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 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: 24081366
• Report Number: 8030229-2026-06084
• Device Sequence Number: 5827640
• Product Code: MHX
• UDI-Device Identifier: 04931921002056
• UDI-Public: (01)04931921002056
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2025
• 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