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

Model Number GF-210RA

Device Problems Use of Device Problem (1670); Application Program Problem (2880)

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

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multigas unit went down with a device failure.According to the customer, they rebooted the unit and attempted again, but the issue remained.The customer requested that the unit 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 went down with a device failure.There was no patient injury reported.

Event Description

The customer reported that the multigas unit went down with a device failure.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the multigas unit went down with a device failure.According to the customer, they rebooted the unit and attempted again, but the issue remained.The customer requested that the unit 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.The following fields are not applicable (na) to this report: b2.D4 lot # & expiration date.D6a & d6b.D7b.F1 - f14.G4 device bla number.G5.G7.H2.H7.H9.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.Attempt # 1: 02/24/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/25/2021 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 02/24/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/25/2021 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 02/24/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/25/2021 emailed the customer via microsoft outlook for patient information: no reply was received.D10 attempt # 1: 02/24/2022 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 02/25/2021 emailed the customer via microsoft outlook for device information: no reply was received.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: 13600774
• MDR Text Key: 286751238
• Report Number: 8030229-2022-02522
• 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: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• 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: 02/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2019
• 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