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

Model Number	GF-210R
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that this multigas unit displayed a gas device error message.The unit was not in patient use at the time.
Additional Manufacturer Narrative
The customer reported that this multigas unit displayed a gas device error message.The issue was discovered during setup.According to the customer, the pump appears to have failed as during warm up, it does not make any sound.After it has warmed up, the error message is displayed.Something appears to be wrong internally with the unit.The unit was not in patient use at the time.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 Manufacturer Narrative
Details of complaint: the customer reported that this multigas unit displayed a gas device error message.The issue was discovered during setup.According to the customer, the pump appears to have failed as during warm up, it does not make any sound.After it has warmed up, the error message is displayed.Something appears to be wrong internally with the unit.The unit was not in patient use at the time.Investigation summary: the device with the reported issue was not returned for evaluation; therefore, a root cause could not be determined.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 01/08/2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 01/12/2026 i called ryan to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for ryan to call me back with this information.Attempt # 3: 01/16/2026 i called ryan to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for ryan to call me back with this information.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type?.H11 additional manufacturer narrative.
Event or Problem Description
The customer reported that this multigas unit displayed a gas device error message.The unit was not in patient use at the time.

• 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: 24145979
• Report Number: 8030229-2026-06065
• Device Sequence Number: 15786711
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: (01)04931921106891
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2021
• 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