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

Model Number GF-210RA

Device Problems Unable to Obtain Readings (1516); Output Problem (3005)

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

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multigas unit had no numeric readings, so he changed the water traps.The numeric readings and co2 readings then came up, but then dropped out a minute later, showing no readings at all.The reported issue happened while in patient use.The unit was replaced with another about ten minutes after the malfunction occurred to continue monitoring co2 readings.There was no patient harm or injury reported.The unit was sent in for an exchange on (b)(6) 2022, but has not yet been evaluated.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.Attempt # 1: on (b)(6) 2022 emailed the customer for patient and concomitant device information: no reply was received.Attempt # 2: on (b)(6) 2022 emailed the customer for patient and concomitant device information: the customer informed nihon kohden this information is not available.

Event Description

The customer reported that the multigas unit had no numeric readings, so he changed the water traps.The numeric readings and co2 readings then came up, but then dropped out a minute later, showing no readings at all.The reported issue happened while in patient use.

Event Description

The customer reported that the multigas unit had no numeric readings, so they changed the water trap.The numeric readings and co2 readings then came up, but then dropped out a minute later, showing no readings at all.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the customer reported that the multigas unit had no numeric readings, so they changed the water trap.The numeric readings and co2 readings then came up, but then dropped out a minute later, showing no readings at all.No patient harm was reported.Investigation summary: the device was sent in for evaluation.During the evaluation of the reported device, nihon kohden repair center (nk rc) was not able to confirm the issue of inaccurate values as well as a gas device error.A gas device error occurs when the unit becomes defective and needs to be repaired.The gas module was replaced with a new revision to resolve the issue.The new revision of the gas module contains a new pump and firmware to address issues related to early failure of the gas module and gas device error messages along with the issue of obtaining accurate readings, if any.As the pump is a wear and tear item, the root cause is likely associated with wear and tear of the pump.The device was installed in (b)(6) 2020 with no history of servicing.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6.B6 - b7.D10.Attempt # 1: (b)(6) 2022 emailed the customer for all information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2022 emailed the customer for all information in the ni list above: the customer informed nihon kohden that this information is not available.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 15728776
• MDR Text Key: 307212778
• Report Number: 8030229-2022-03182
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: 04931921106891
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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
• Date Returned to Manufacturer: 10/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2021
• 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: BSM; BSM