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

Model Number	GF-210RA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the multigas unit was working intermittently during a procedure.No patient harm reported.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.Concomitant medical device information was requested from the customer, but they only knew that it was being used with a csm-1901, but they did not know the serial number.
Event or Problem Description
The biomedical engineer reported that the multigas unit was working intermittently during a procedure.No patient harm reported.
Additional Manufacturer Narrative
Details of the complaint: on (b)(6) 2019, customer at medical center @ (b)(6) reported the multigas unit (gf-210ra sn: (b)(6)) was intermittently going in and out.Service requested: repair.Service performed: upgrade firmware of cd-314p-02 from ver-04.08.00 to ver-04-23.01 per mtbin 038.Investigation result: review shows the unit displaying "gas external device failure" error message.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)) needed a firmware upgrade.Revision 2 of cd-314p utilized a new pump with a slight difference in specification.The sensor unit detects this small difference and outputs message of gas device error.The resolution was to perform a firmware upgrade.The root cause of the error message on serial number (b)(6) was due to firmware requiring upgrade.Serial numbers above (b)(6) are not affected.Investigation conclusion: the root cause of the error message on serial number (b)(6) was due to firmware requiring upgrade.D11: concomitant medical device information was requested from the customer, but they only knew that it was being used with a csm-1901, but they did not know the serial number.
Event or Problem Description
The biomedical engineer reported that the multigas unit was working intermittently during a procedure.No patient harm reported.

• 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: 8872044
• Report Number: 8030229-2019-00348
• Device Sequence Number: 13509532
• Product Code: CCK
• UDI-Device Identifier: 04931921115305
• UDI-Public: 04931921115305
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K110594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019
• Report Date (Section F): 12/19/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/18/2019
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CSM-1901; CSM-1901
• Date Report Sent to FDA: 12/19/2019