MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GF-210R; MULTI-GAS UNIT

Model Number	GF-210R
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the multigas unit was not measuring end-tidal co2 (etco2).There were no reports of patient harm.Investigation summary: the defective unit (sn: (b)(6)) was later returned and evaluated.A physical inspection confirmed the model and serial number, with no visible damage or signs of liquid intrusion; however, the water trap was missing.Functional testing using visia2 software with a bsm-6000 connection successfully reproduced the reported issue.Further evaluation determined that the internal pump had failed, preventing proper measurement of end-tidal co2.The device had a total operating time of 5,271 hours.The failure to measure end-tidal co2 was caused by an internal pump failure within the gf-210ra unit, resulting in loss of gas sampling capability.The missing water trap may have contributed to wear or stress on the pump but was not definitively confirmed as the direct cause of failure.Trending for similar issues and devices will continue to be monitored by nihon kohden.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the multigas unit: g5 monitor: model #: cu-152r.Serial #: (b)(6).Device manufacturer data: 12/06/2024 (dec.).Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.
Event or Problem Description
The biomedical engineer (bme) reported that the multigas unit was not measuring end-tidal co2 (etco2).There were no reports of patient harm.

• Brand Name: GF-210R
• Common Device Name: MULTI-GAS UNIT
• 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: 24938847
• Report Number: 8030229-2026-06459
• Device Sequence Number: 5168229
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: (01)04931921106891
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110594
• 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): 04/21/2026

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: GF-210R
• Device Catalogue Number: GF-210R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: G5 MONITOR.
• Patient Sex: Unknown