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	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that the multigas unit was giving an external gas error.They replaced this unit with another one and it operated without issue.The unit that failed was warmed up between 45 minutes - 1 hour.They are measuring desflurane.No signs of physical damage or fluid intrusion.The aux cable was properly connected.This problem occurred 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 when additional information becomes available.Bedside monitor: mu-910ra, sn (b)(4).
Event or Problem Description
The biomedical engineer reported that the multigas unit was giving an external gas error.No patient harm reported.
Event or Problem Description
The biomedical engineer reported that the multigas unit was giving an external gas error.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: on 07/18/19 customer at (b)(6) reported the multigas unit (gf-210ra sn: (b)(6) was generating an external device failure error.Investigation conclusion: in summary, serial numbers (b)(6) to (b)(6) have version 2 of cd-314p.These units require firmware upgrade.The root cause of the error message on serial number (b)(6) was due to design change flaw which caused pumps with new/different specifications to be used in manufacturing.Capa 19-016 has been opened to address the issue and is in progress.The overall risk is high.Disposition of complaint: tracking and trending will be conducted as part of capa 19-016 effectiveness check as well as during quarterly qa review.

• 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: 8881113
• Report Number: 8030229-2019-00362
• Device Sequence Number: 14004785
• Product Code: CCK
• UDI-Device Identifier: 04931921115305
• UDI-Public: 04931921115305
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/04/2020
• Report Date (Section F): 03/04/2020

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: 10/17/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/20/2020
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 03/04/2020
• 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: MU-910RA SN (B)(6); MU-910RA SN (B)(6)
• Date Report Sent to FDA: 03/04/2020