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 12/28/2021

Event Type  malfunction  

Event Description

The customer reported that the multigas unit intermittently stops reading gases.There was no patient injury reported.

Manufacturer Narrative

According to the customer, the unit displays no errors, it just stops generating readings.The customer will send in the unit to be exchanged.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 intermittently stops reading gases.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the multigas unit intermittently stops reading gases.According to the customer, the unit displays no errors, it just stops geerating readings.The customer will send in the unit to be exchanged.There was no patient injury reported.Investigation summary: the root cause of the reported issue is attributable to the state of wear-components such as watertrap, connectors, sampling line, and/or device damage.Manufacturer references # (b)(4) follow up 001.

• 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: 13359356
• MDR Text Key: 284619854
• Report Number: 8030229-2022-02400
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2019
• 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