MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION AG-920RA; MULTI-GAS UNIT

Model Number	AG-920RA
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device was returned to nihon kohden; however, device evaluation anticipated, but not yet begun.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
The customer reported that the multi-gas unit is giving incorrect readings while on a patient.No consequence or impact to patient.
Additional Manufacturer Narrative
Details of the complaint: customer reported that while in use on patient, gas was reading fine until halfway through the case it began to act erratically.New water trap and sampling line were tried, no change.User decide to send unit in for repair and requested a loaner.Unit was cleaned and evaluated by nka repair center; reported issue was verified and duplicated.Gas sensor unit cd-237p was replaced and the gas reading issue was resolved.The root cause of the issue was a faulty cd-237p gas sensor unit.Repair center replaced the gas sensor unit and retested it, all gas readings were good displays.The repaired unit operated according to manufacturer specifications.The previous issue was readily identifiable by the user and necessary precautions were able to be taken to ensure patient safety.There was no known impact or consequence to the patient that was reported.This complaint record does not require further investigation and can be qa closed as investigational information within the record indicates that the issue was resolved by replacing a faulty gas sensor unit.

• Brand Name: AG-920RA
• 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: 7947947
• Report Number: 8030229-2018-00392
• Device Sequence Number: 770186
• Product Code: CCK
• UDI-Device Identifier: 00841983103162
• UDI-Public: 00841983103162
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K020046
• 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): 10/09/2018
• Report Date (Section F): 10/09/2018

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: AG-920RA
• Device Catalogue Number: AG-920RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/13/2018
• Device Age: 95 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 03/12/2019
• 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: 10/09/2018