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

Model Number	GF-210R
Medical Device Problem Codes	Unable to Obtain Readings (1516); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the multigas unit gave a "gas device error" message and gave no gas readings.He tried changing out the water trap and line, but the issue persisted.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: d10 concomitant medical device: the following device(s) were used in conjunction with the multigas unit: bedside monitor (bsm): model #: mu-651ra serial #: (b)(6) device manufacturer data: 02/09/2014 unique identifier (udi) #: (b)(4) returned to nihon kohden: na.
Event or Problem Description
The customer reported that the multigas unit gave a "gas device error" message and gave no gas readings.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the multigas unit gave a "gas device error" message and gave no gas readings.He tried changing out the water trap and line, but the issue persisted.No patient harm was reported.Investigation summary: the device was sent to nk for evaluation and repair.A visual inspection confirmed that no visible physical damage, scratches, or signs of liquid exposure were observed.The device was received without a water trap.The total operating time recorded was 59,541 hours, with software version 01-04 and firmware revision 04.10.00.Functional testing was performed using visia2 software with a bsm-6000 connected.During testing, a "check device" error message was successfully duplicated.Further evaluation confirmed that the issue was caused by a defective pump, which requires replacement.Nihon kohden will continue to trend and monitor.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the multigas unit: bedside monitor (bsm): model #: mu-651ra, serial #: (b)(6), device manufacturer data: 02/09/2014, unique identifier (udi) #: (b)(4), returned to nihon kohden: na.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? h6.Event problem and evaluation codes.H11.Additional manufacturer narrative.
Event or Problem Description
The customer reported that the multigas unit gave a "gas device error" message and gave no gas readings.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: 24533425
• Report Number: 8030229-2026-06293
• Device Sequence Number: 13029476
• 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): 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: 03/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2015
• 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: BEDSIDE MONITOR (MU-651RA, SN: (B)(6).; BEDSIDE MONITOR (MU-651RA, SN: (B)(6).
• Patient Sex: Unknown