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

Model Number	GF-210R
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the multigas unit will not run, and there is a gas line blocked error message.They can hear the pump run, then it stops and an error messages "gas line blocked" pops up on the bsm display.Customer also states that when the pump is running, it sounds terrible, like the pump is struggling.The customer verified there are not blocked gas lines, the unit is running to the open air, no line connected at all, and the error message still appears and the pump still sounds like it is struggling.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 bedside monitor model: mu-631ra sn: (b)(6).
Event or Problem Description
The biomedical engineer (bme) reported that the multigas unit will not run, and there is a gas line blocked error message.They can hear the pump run, then it stops and an error messages "gas line blocked" pops up on the bsm display.Customer also states that when the pump is running, it sounds terrible, like the pump is struggling.The customer verified there are not blocked gas lines, the unit is running to the open air, no line connected at all, and the error message still appears and the pump still sounds like it is struggling.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the multigas unit will not run, and there is a gas line blocked error message.They can hear the pump run, then it stops and an error messages "gas line blocked" pops up on the bsm display.Customer also states that when the pump is running, it sounds terrible, like the pump is struggling.The customer verified there are not blocked gas lines, the unit is running to the open air, no line connected at all, and the error message still appears and the pump still sounds like it is struggling.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the multigas unit will not run, and there is a gas line blocked error message.They can hear the pump run, then it stops and an error messages "gas line blocked" pops up on the bsm display.Customer also states that when the pump is running, it sounds terrible, like the pump is struggling.The customer verified there are not blocked gas lines, the unit is running to the open air, no line connected at all, and the error message still appears and the pump still sounds like it is struggling.No patient harm was reported.Investigation conclusion: the unit was within warranty with no signs of physical damage or fluid intrusion, and a warranty exchange was processed.Inspection of the returned unit duplicated the issue, with the alarm log showing repeated line block errors preceding a gas device error, and the abnormal pump sound was attributed to internal pump malfunction.Root cause: component failure.Additional device information: d10 concomitant medical device.Bedside monitor: model: mu-631ra, sn: (b)(6).Additional information: b4.Date of this report, d9.Device available for evaluation, 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.

• 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: 24185651
• Report Number: 8030229-2026-06132
• Device Sequence Number: 13149111
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: (01)04931921106891
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/09/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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: MU-631RA SN (B)(6).; MU-631RA SN (B)(6).
• Patient Sex: Unknown