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	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the multi-gas unit was providing a external device failure error message.They tried a new sampling line and a new water trap, but there was no change.This issue follows the gas module.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the multi-gas unit was providing a external device failure error message.They tried a new sampling line and a new water trap, but there was no change.This issue follows the gas module.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 02/05/2025 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.Received.Bedside monitor model: cu-192ri sn: ni.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the multi-gas unit was providing a external device failure error message.They tried a new sampling line and a new water trap, but there was no change.This issue follows the gas module.No patient harm was reported.Investigation conclusion: the customer reported that the multi-gas unit was providing an external device failure error message.The complaint device was returned to nihon kohden for evaluation and repair.During testing, the reported issue was duplicated, and the cause of the issue was determined to be a pump that had failed after 24413 hours of use.After replacement of the malfunctioning component, the device performed to manufacturer's specifications.This issue was previously reported in ticket (b)(4), but the customer stated that it had been resolved in (b)(6) 2025.It is unclear if the device's issue was intermittent at that stage or if the device had been removed from service at the customer facility.A review of the device's complaint history by serial number reveals no similar issues.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.Bedside monitor: model: cu-192ri, sn: ni.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 multi-gas unit was providing a external device failure error message.They tried a new sampling line and a new water trap, but there was no change.This issue follows the gas module.No patient harm was reported.

• 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: 24396070
• Report Number: 8030229-2026-06208
• Device Sequence Number: 9926616
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: (01)04931921106891
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/17/2026

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: 02/04/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CU-192R SN NI.; CU-192R SN NI.
• Patient Sex: Unknown