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

Model Number GF-210RA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

Event Type  malfunction  

Event Description

The customer reported that this multigas unit was generating erroneous readings during a case.There was no patient injury reported.

Manufacturer Narrative

The customer reported that this multigas unit was generating erroneous readings during a case.The customer changed out the water trap and sample line, but the issue remained.The customer replaced the unit with a different one and the replacement worked properly.There was no patient injury 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have this information.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have this information.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have this information.(b)(6) 2023 emailed the customer via microsoft outlook for device information: the customer replied by stating; i do not have this information.

Event Description

The customer reported that this multigas unit was generating erroneous readings during a case.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this multigas unit was generating erroneous readings during a case.The customer changed out the water trap and sample line, but the issue remained.The customer replaced the unit with a different one and the replacement worked properly.There was no patient injury reported.Investigation summary: during evaluation of the device, we were unable to confirm the complaint, as there were no issues found with the device.We replaced the following part: pump for gf-210ra, part number 6104902637 and updated the firmware to revision 04.23.02, as preventative measures.Based on the available information, we were unable to confirm the reported issue, as there were no issues found with the device during evaluation.Attempt # 1: 04/06/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have this information.Attempt # 1: 04/06/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have this information.Attempt # 1: 04/06/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have this information.04/06/2023 emailed the customer via microsoft outlook for device information: the customer replied by stating; i do not have this information.Manufacturer references # (b)(4).

• Brand Name: GF-210RA
• Type of Device: 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: 16773720
• MDR Text Key: 313642330
• Report Number: 8030229-2023-03452
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-210RA
• Device Catalogue Number: GF-210RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NI.; NI.