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	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the multigas unit did not display a co2 reading on the monitor while in patient use.They tried changing out the water trap, but the issue persisted.No patient harm was reported.
Additional Manufacturer Narrative
The customer initially reported that a cns (pu-621ra, sn: (b)(6) was experiencing signal loss.There was a lot of confusion on the part of the customer as to what device she was supposed to report on and what type of device failure had occurred.She was later able to find the appropriate device model and incident details, but not until 02/11/2026, which was when nk became aware that this multigas unit did not display a co2 reading on the monitor while in patient use.They tried changing out the water trap, 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 was used in conjunction with the multigas unit: g5 monitor: model #: cu-151ra serial #: (b)(6) device manufacturer data: 07/17/2024 unique identifier (udi) #: (b)(4) returned to nihon kohden: na.
Additional Manufacturer Narrative
Details of complaint: the customer initially reported that a cns (pu-621ra, sn: (b)(6)) was experiencing signal loss.There was a lot of confusion on the part of the customer as to what device she was supposed to report on and what type of device failure had occurred.She was later able to find the appropriate device model and incident details, but not until 02/11/2026, which was when nk became aware that this multigas unit failed to display a co2 reading on the monitor while in patient use.They tried changing out the water trap, but the issue persisted.No patient harm was reported.Investigation summary: the device was sent to nk for evaluation and repair.The reported issue was duplicated, and the device gave a "gas device error" message after powering it on.The cause of the issue was confirmed to be hardware failure, but the device was deemed irreparable because the hardware (gas module cd-314p-01) was older and incompatible with the available replacement parts.The customer was advised to proceed with an exchange or purchase a new device.A review of the device's complaint history revealed that the same device failure was reported in july 2025 in ticket (b)(6).No further action was taken due to non-response from the customer after multiple attempts.The complaint device was installed at the customer facility in july 2014, and the hardware failure was likely due to age or accumulated wear and tear.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: g5 monitor: model #: cu-151ra, serial #: (b)(6), device manufacturer data: 07/17/2024, 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 failed to display a co2 reading on the monitor while in patient use.They tried changing out the water trap, but the issue persisted.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: 24510183
• Report Number: 8030229-2026-06290
• Device Sequence Number: 10053185
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: (01)04931921106891
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/20/2026

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: 02/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2014
• 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: G5 MONITOR (CU-151RA, SN: (B)(6)); G5 MONITOR (CU-151RA, SN: (B)(6))
• Patient Sex: Unknown