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

Model Number GF-210RA

Device Problem Output Problem (3005)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multigas unit is displaying "gas analyzer failure" error.No harm or injury was reported.The customer will be sending this unit in for an exchange.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.

Event Description

The customer reported that the multigas unit is displaying "gas analyzer failure" error.No harm or injury was reported.The customer will be sending this unit in for an exchange.

Manufacturer Narrative

Details of complaint: the customer reported that the multigas unit was displaying a "gas analyzer failure" error message.They changed the water trap, but the issue persisted.They were provided with an exchange.No patient harm was reported.Investigation summary: the root cause is determined to be component failure.The sensor needed replacing.The sensor is a replaceable component, where the longevity is dependent upon the following factors: instrument and parts must undergo regular maintenance inspection at least every 6 months.If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition.Water trap should be replaced every 4 weeks or as indicated on the device.Ensuring the environment is optimal as described in the operator's manual.

Event Description

The customer reported that the multigas unit is displaying "gas analyzer failure" error.No harm or injury was reported.

• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10226472
• MDR Text Key: 198359448
• Report Number: 8030229-2020-00357
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/02/2020,03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• 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: 06/18/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2020
• Distributor Facility Aware Date: 06/11/2020
• Device Age: 55 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2020
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2015
• 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