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	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the multi gas unit was not giving readings when connected to a bedside monitor.This was discovered during a case, so troubleshooting was limited before swapping out the unit.They tried swapping cables with no change.Customer swapped this gas unit with another one and data came across immediately, issue appears to be with this unit.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: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device.Attempt #1 01/30/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 02/03/2025 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they did not provide the additional device information.Bedside monitor model: ni sn: ni.
Event or Problem Description
The biomedical engineer (bme) reported that the multi gas unit was not giving readings when connected to a bedside monitor.This was discovered during a case, so troubleshooting was limited before swapping out the unit.They tried swapping cables with no change.Customer swapped this gas unit with another one and data came across immediately, issue appears to be with this unit.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the multi gas unit was not giving readings when connected to a bedside monitor.This was discovered during a case, so troubleshooting was limited before swapping out the unit.They tried swapping cables with no change.Customer swapped this gas unit with another one and data came across immediately, issue appears to be with this unit.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the multi gas unit was not giving readings when connected to a bedside monitor.This was discovered during a case, so troubleshooting was limited before swapping out the unit.They tried swapping cables with no change.Customer swapped this gas unit with another one and data came across immediately, issue appears to be with this unit.No patient harm was reported.Investigation conclusion: on (b)(6) 2026, the customer reported that the gf-210ra multigas unit was not providing readings when connected to a bsm monitor.The issue was discovered during a patient case; however, troubleshooting was limited before the unit was swapped out.The customer confirmed that there was no patient harm.Swapping cables did not resolve the issue.When the gas unit was replaced with another unit, readings were immediately restored, indicating the issue was isolated to the reported device.Upon receipt, the unit was cleaned and decontaminated.Physical inspection confirmed the model and serial number, with no visible damage, scratches, or signs of liquid exposure.The unit received with water trap missing.The unit had 2,591 operating hours.Software version 01-11 and firmware revision 04.23.02 were verified.Functional testing was performed using visia2 software with a bsm-6000 connection.During evaluation, the reported issue was successfully duplicated.The monitor displayed a "line block / gas device failure" error.Further testing confirmed internal pump failure.Replacement of the internal pump or gas module is required.Root cause summary/results: the reported issue was caused by an internal pump malfunction within the gf-210ra gas module.Additional device information: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device.Bedside monitor model: ni, sn: ni.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: 24310168
• Report Number: 8030229-2026-06195
• Device Sequence Number: 11980602
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: (01)04931921106891
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/03/2026

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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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: BEDSIDE MONITOR.; BEDSIDE MONITOR.
• Patient Sex: Unknown