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

Model Number	GF-210RA
Medical Device Problem Codes	No Device Output (1435); Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the multigas unit intermittently displayed a "check water trap" error message while monitoring the patient.No consequence or impact to the patient was 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.
Event or Problem Description
It was reported that the multigas unit intermittently displayed a "check water trap" error message while monitoring the patient.No consequence or impact to the patient.
Event or Problem Description
It was reported that the multigas unit intermittently displayed a "check water trap" error message while monitoring the patient.No consequence or impact to the patient.
Additional Manufacturer Narrative
Details of the complaint: on (b)(6) 2019, customer at columbus community hospital reported the multigas unit (gf-210ra sn: (b)(6) ) received intermittent "check water trap" error message.Service requested/performed: exchange; nka repair center evaluation of the returned unit: the unit was cleaned and decontaminated.The model, serial number, and all labels were verified physical evaluation: no physical damage nor fluid intrusion.Verify the complaint: cannot verify check water trap complaint.Unit passed test.No error message found.Investigation conclusion: the device warranty began 07/30/15, and the issue was reported after approximately 4 years at customer facility.Evaluation of the unit at nka was unable to duplicate the reported issue.No error message was found during evaluation and the unit passed rc test.As the reported issue could not be reproduced, the root cause could not be determined.No risk analysis is performed as evaluation of the unit at nka did not identify a non-conformance.

• 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: 8903837
• Report Number: 8030229-2019-00386
• Device Sequence Number: 10819792
• Product Code: CCK
• UDI-Device Identifier: 04931921115305
• UDI-Public: 04931921115305
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/27/2020
• Report Date (Section F): 03/27/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/24/2020
• Device Age: 53 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 03/26/2020
• 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: 03/27/2020