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	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that this multigas unit displayed a "gas device error" message.The issue was discovered during setup.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 device information: d10 concomitant medical device: the following device(s) were used in conjunction with the multigas unit: bedside monitor (bsm).Model #: bsm-6501a.Serial #: (b)(6).Device manufacturer date: mm/dd/yyyy.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: no.
Event or Problem Description
The customer reported that this multigas unit displayed a "gas device error" message.The issue was discovered during setup.The unit was not in patient use at the time.
Event or Problem Description
The customer reported that this multigas unit displayed a "gas device error" message.The issue was discovered during setup.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.The unit was not in patient use at the time.Investigation conclusion: the customer reported that this multigas unit displayed a "gas device error" message.Upon follow up, the customer requested that the ticket be cancelled because the unit was already repaired.As of 06/05/2026, there is no record of the device being returned for service at nihon kohden, and the cause of the complaint remains unknown.It is unclear if the customer resolved the issue through further troubleshooting or performed self-repair.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the multigas unit: bedside monitor (bsm): model #: bsm-6501a.Serial #: (b)(6).Device manufacturer date: mm/dd/yyyy.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: no.

• 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: 24756141
• Report Number: 8030229-2026-06349
• Device Sequence Number: 9165802
• 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,Followup
• Report Date (Section B): 06/09/2026

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: 03/11/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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: BSM-6501A/SN (B)(6). ; BSM-6501A/SN (B)(6).
• Patient Sex: Unknown