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

Model Number	GF-210RA
Medical Device Problem Codes	No Device Output (1435); Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the multigas unit (gf-210ra) failed during patient use.The numeric values and waveform were dropping out and the device went into a flat line.No consequence or impact to the patient was reported.The customer has checked all the connections and settings but was unable to find the cause.The customer also indicated that the numeric values and waveform came back but then disappeared a few minutes after.The customer will send in the defective unit for an evaluation.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 or Problem Description
It was reported that the multigas unit (gf-210ra) failed during patient use.The numeric values and waveform were dropping out and the device went into a flat-line.No consequence or impact to the patient was reported.
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2019 customer stated gas unit was not reading etco2.No errors were reported.Device was then sent to nka for firmware update under a different record: (b)(4).Service requested: exchange.Service performed: exchange.Investigation conclusion: the root cause of reported issue was determined to be firmware related.An update is required to correct this issue.Capa 19-016 has been initiated.Additional information: b4.Date of this report; f6.Date user facility/importer became aware of the event; f7.Type of report; f11.Date report sent to fda; f13.Date report sent to manufacturer; g4.Date received by manufacturer; g7.Type of report; h2.If follow-up, what type?; h6.Event problem and evaluation codes; h10.Additional manufacturer narrative.
Event or Problem Description
It was reported that the multigas unit (gf-210ra) failed during patient use.The numeric values and waveform were dropping out and the device went into a flat-line.No consequence or impact to the patient was 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: 9090464
• Report Number: 8030229-2019-00475
• Device Sequence Number: 11337237
• Product Code: CCK
• UDI-Device Identifier: 04931921115305
• UDI-Public: 04931921115305
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/27/2020
• Report Date (Section F): 02/27/2020

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: 02/21/2020
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 02/27/2020
• 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: 02/27/2020