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

Model Number	GF-210RA
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the multigas unit gave an "external module failure" error message during warm up and it did not go away.The customer was unable to confirm if the unit was in patient use at the time the issue occurred.No patient harm or injury was reported.The customer would like to send the 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 if additional information becomes available.
Event or Problem Description
The biomedical engineer reported that the multigas unit gave an "external module failure" error message during warm up and it did not go away.
Event or Problem Description
The biomedical engineer reported that the multigas unit gave an "external module failure" error message during warm up and it did not go away.
Additional Manufacturer Narrative
Details of complaint: on 8/14/2019 customer stated gas unit was causing an external module failure when connected to monitoring device.The monitoring device model and serial number was not provided.Device received firmware update under notification 300179365 on 8/23/2019.Service requested: exchange.Service performed: exchange.Investigation result: the investigation under (b)(4) concluded that for gf-210ra revision cb and onward with sensor unit cd-314p revision 2 (serial numbers (b)(4)) 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)(4) and below has the first version of cd-314p.Serial numbers (b)(4) have version 2 of cd-314p.These units require firmware upgrade.Serial numbers above (b)(4) are not affected.The root cause of the error message on serial number (b)(4) was due to firmware requiring upgrade.Investigation conclusion: firmware upgrade needed.

• Brand Name: GF-210RA
• Common Device Name: 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: 8967771
• Report Number: 8030229-2019-00438
• Device Sequence Number: 13975265
• Product Code: CCK
• UDI-Device Identifier: 04931921115305
• UDI-Public: 04931921115305
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K110594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019
• Report Date (Section F): 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GF-210RA
• Device Catalogue Number: GF-210RA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/15/2019
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/05/2019