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 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this multigas unit intermittently does not pick up readings.According to the customer, they have changed the water trap and rebooted the unit, but the issue persists.When the issue occurs, the device does not display any error messages.The unit is being exchanged.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.Additional model information: concomitant medical device: the following device was used in conjunction with the gf-210ra: bsm: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.

Event Description

The customer reported that this multigas unit intermittently does not pick up readings.There was no patient injury reported.

Event Description

The customer reported that the multigas unit was intermittently not giving readings.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the multigas unit was intermittently not giving readings.They changed out the water trap and rebooted the unit, but the issue persists.There were also no error messages displayed.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 able to confirm the issue of the device showing 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.As the pump is a wear and tear item, root cause is likely associated to wear and tear of the pump.Attempt # 1: 07/01/2022 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 07/08/2022 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3 07/13/2022 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the multigas unit (gf-210ra): bsm: model #: ni; serial #: ni; device manufacturer data: ni; unique identifier (udi) #: ni; returned to nihon kohden: ni.

• 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: 15116929
• MDR Text Key: 304549424
• Report Number: 8030229-2022-02991
• 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• 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: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2020
• 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.