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

Model Number	CU-172R
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the g7 monitor displayed a "comm loss" while in patient use.The g7 was connected to a drager atlan anesthesia machine.They tried replacing the network cable, changing data jacks and the switch port, and power cycling the bsm; however, the issue persisted.A different g7 monitor was connected using the original data jack and network cable and functioned normally.Further troubleshooting of the affected g7 included three reinitializations and reloading of clinical configurations, but the monitor continued to remain in "comm loss." no reports of patient harm.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.The following field contains no information (ni), as attempts to obtain the information was made, but not provided: d10 attempt # 1: (b)(6) 2026 emailed the bme via microsoft outlook for the information in the ni list above: the bme replied, stating that the requested information was unknown.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the g7 monitor: drager atlan anesthesia machine (3rd party device).Model #: ni.Serial #: ni.Device manufacturer date: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.Transport unit / dau.Model #: ni.Serial #: ni.Device manufacturer date: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.
Event or Problem Description
The biomedical engineer (bme) reported that the g7 monitor displayed a "comm loss" while in patient use.The g7 was connected to a drager atlan anesthesia machine.No patient harm was reported.

• 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: 24859637
• Report Number: 8030229-2026-06424
• Device Sequence Number: 10475979
• Product Code: MHX
• UDI-Device Identifier: 04931921004517
• UDI-Public: (01)04931921004517
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 06/24/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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: ANESTHESIA MACHINE.; TRANSPORT UNIT / DAU.
• Patient Sex: Unknown