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	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the multi-gas unit was giving an external device failure error.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: 02/10/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 02/12/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: 02/16/2026 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Bedside monitor.Model: ni.Sn: ni.
Event or Problem Description
The biomedical engineer (bme) reported that the multi-gas unit was giving an external device failure error.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the multi-gas unit was giving an external device failure error.No patient harm was reported.Investigation conclusion: the complaint device was returned to nihon kohden for evaluation and repair.During testing, the reported issue was duplicated, and the cause of the issue was determined to be a pump that had failed after 31,722 hours of use.After replacement of the malfunctioning component, the device performed to manufacturer's specifications.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, 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 biomedical engineer (bme) reported that the multi-gas unit was giving an external device failure error.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: 24397136
• Report Number: 8030229-2026-06224
• Device Sequence Number: 20905305
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: (01)04931921106891
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/17/2026

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: 02/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2018
• 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