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

Model Number GF-210RA

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the multigas unit failed and gave a "gas device" error message.No consequence or impact to the patient was reported.The reported device was returned to nihon kohden; however, device evaluation anticipated, but not yet begun.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported that the multigas unit failed and gave a "gas device" error message.No consequence or impact to the patient was reported.

Manufacturer Narrative

Details of complaint: on (b)(6) 2019 customer stated gas unit was giving a "gas device error".Nka repair center update firmware to version 04-23.01 to resolve the issue.Service requested: exchange.Service performed: exchange.Investigation result: the investigation under irc-nka300155492 concluded that for gf-210ra revision cb and onward with sensor unit cd-314p revision 2 (serial numbers (b)(6) to (b)(6) needed a firmware upgrade.Revision 2 of cd-314p utilize a new pump with a slight difference in specification.The sensor unit detects this small difference and output as gas device error.The resolution was to perform a firmware upgrade.For gf-210ra with older sensor unit cd-314p (no revision # = first revision), there was no tendency of sensor failing, thus the investigation provided no countermeasure.Due to no tendency of failure, it was determined these sensors failed as a result of normal usage.Cd-314p replacement is recommended.In summary, serial numbers (b)(6) and below has the first version of cd-314p.Serial numbers (b)(6) to (b)(6) have version 2 of cd-314p.These units require firmware upgrade.Serial numbers above (b)(6) are not affected.The root cause of the error message on serial number (b)(6) was due to firmware requiring upgrade.F6.Date user facility/importer became aware of the event.

Event Description

It was reported that the multigas unit failed and gave a "gas device" error message.No consequence or impact to the patient was reported.

• Brand Name: GF-210RA
• Type of Device: MULTI-GAS UNIT
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 8853202
• MDR Text Key: 160900038
• Report Number: 8030229-2019-00329
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: 4931921106891
• Combination Product (y/n): N
• PMA/PMN Number: K110594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• 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: 07/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2019
• Distributor Facility Aware Date: 10/14/2019
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2019
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1