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

Model Number	AG-920RA
Medical Device Problem Codes	Gas Output Problem (1266); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the multi-gas unit was showing low gas readings while in patient use.The customer sent the unit in for repair and requested a loaner device in the meantime.When the device was evaluated by nihon kohden, a "cal error" message appeared after the unit was warmed up.The issue of "low gas readings" could not be duplicated.Nihon kohden technical support (nk ts) is working on completing the repair process for the customer.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 was showing low gas readings while in patient use.
Additional Manufacturer Narrative
Details of the complaint: on (b)(6) 2020, (b)(6) at (b)(4) reported the multi gas unit (ag-920a sn: (b)(6)) had low gas readings.Investigation summary: based on the age of the unit, probable root cause is normal deterioration of the gas sensor unit cd-237p.Due to the product discontinuation, replacement parts were not available and the unit was not repaired.
Event or Problem Description
The customer reported that the multi-gas unit was showing low gas readings while in patient use.

• 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: 9734943
• Report Number: 8030229-2020-00099
• Device Sequence Number: 355292
• Product Code: CCK
• UDI-Device Identifier: 00841983103162
• UDI-Public: 00841983103162
• Combination Product (Y/N): N
• 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): 06/03/2020
• Report Date (Section F): 06/03/2020

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: AG-920RA
• Device Catalogue Number: AG-920RA
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/02/2020
• Device Age: 90 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 06/03/2020
• 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: 06/03/2020