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

Model Number	GF-210R
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the multigas unit was giving a line block error upon powering it on, then it progressed to a gas device failure error.The customer verified that the lines are clear and unkinked.The customer tried using a brand-new water trap and even tried running without a water-trap for testing and nothing yielded any change in behavior.Not in patient use.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: cu-152ri.Sn: (b)(6).
Event or Problem Description
The biomedical engineer (bme) reported that the multigas unit was giving a line block error upon powering it on, then it progressed to a gas device failure error.The customer verified that the lines are clear and unkinked.The customer tried using a brand-new water trap and even tried running without a water-trap for testing and nothing yielded any change in behavior.Not in patient use.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the multigas unit was giving a line block error upon powering it on, then it progressed to a gas device failure error.The customer verified that the lines are clear and unkinked.The customer tried using a brand-new water trap and even tried running without a water-trap for testing and nothing yielded any change in behavior.Not in patient use.Investigation conclusion: incident summary: on 01/13/2026, a gf-210ra multigas unit (sn: (b)(6)) displayed repeated "line block" messages followed by a "gas device failure" error when powered on.The unit started with a csm-1502 bedside monitor (sn: (b)(6)) but later tested with another csm-1502 (sn: (b)(6)).The system maintained its original problems throughout both tests.The customer performed several troubleshooting steps which included checking that all sampling lines stayed free of blockages, but they did not solve the problem.The unit was returned for evaluation.Inspection confirmed correct model and serial number, with no visible damage or signs of liquid exposure.The functional testing established the exact errors which had been reported through the visia2 software connection to the bsm-6000 system.The internal pump test showed that it had failed therefore the pump and gas module need to be replaced.No injuries, harm, or adverse events were reported because of this issue.Root cause summary/results: the cause of the reported "line block / gas device failure" errors were identified as a failure of the internal pump within the gf-210ra multigas unit.During functional testing, the issue was successfully duplicated, and the unit consistently displayed the same error messages across multiple compatible bedside monitors and configurations.The system was not in use for patient care at the time.Additional device information: d10 concomitant medical device.Bedside monitor.Model: cu-152ri.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.
Event or Problem Description
The biomedical engineer (bme) reported that the multigas unit was giving a line block error upon powering it on, then it progressed to a gas device failure error.The customer verified that the lines are clear and unkinked.The customer tried using a brand-new water trap and even tried running without a water-trap for testing and nothing yielded any change in behavior.Not in patient use.

• 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: 24141485
• Report Number: 8030229-2026-06103
• Device Sequence Number: 13133247
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: (01)04931921106891
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 01/28/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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: CU-152R, SN (B)(6). ; CU-152R, SN (B)(6).
• Patient Sex: Unknown