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	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that this multigas unit displayed a check device error message.The customer tested the unit on multiple bedsides using new cables and a new water trap; however, the issue persisted.There was no patient injury 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: d10 concomitant medical device: the following device(s) were used in conjunction with the multigas unit: bedside monitor (bsm): model #: cu-152ra serial #: (b)(6) device manufacturer data: 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 check device error message.There was no patient injury reported.
Event or Problem Description
The customer reported that this multigas unit displayed a check device error message.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that this multigas unit displayed a check device error message.The customer tested the unit on multiple bedsides using new cables and a new water trap; however, the issue persisted.There was no patient injury reported.Investigation summary: the device with the reported issue was returned for evaluation.During the evaluation, the reported issue could not be duplicated; therefore, a root cause could not be determined.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the multigas unit: bedside monitor (bsm): model #: cu-152ra, serial #: (b)(6), device manufacturer data: mm/dd/yyyy, unique identifier (udi) #: (b)(4), returned to nihon kohden: no.Additional information: b4.Date of this report, g3.Date received by manufacturer, g6.Type of report, h2.If follow up, what type? h3.Device evaluated by manufacturer? h11.Additional manufacturer narrative.

• 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: 24314844
• Report Number: 8030229-2026-06173
• Device Sequence Number: 5572400
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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
• Date Returned to Manufacturer: 02/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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-152RA.; CU-152RA.
• Patient Sex: Unknown