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

Model Number GF-210RA

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the unit read gases only intermittently.The unit was sent in for repair.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.Attempt # 1: 05/18/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/02/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 06/03/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: 05/18/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/02/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 06/03/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: 05/18/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/02/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 06/03/2021 emailed the customer via microsoft outlook for patient information: no reply was received.

Event Description

The customer reported that the multigas unit was reading gases only intermittently.

Manufacturer Narrative

Details of complaint: the customer reported that the unit read gases only intermittently.The unit was sent in for repair.There was no patient injury reported.Investigation summary: due to insufficient information provided, the root cause of the reported issue could not be determined.Manufacturer references # (b)(4) follow up 001.

Event Description

The customer reported that the multigas unit was reading gases only intermittently.

• 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: 11970206
• MDR Text Key: 262002877
• Report Number: 8030229-2021-00327
• 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: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2014
• 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