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

Model Number	AG-920RA
Medical Device Problem Codes	Unable to Obtain Readings (1516); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bme would like to send the unit in for repair.The device was in use on a patient, however, no patient harm 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
The biomedical engineer (bme) reported that the multigas unit intermittently stopped giving gas readings.
Event or Problem Description
The biomedical engineer (bme) reported that the multigas unit intermittently stopped giving gas readings.
Additional Manufacturer Narrative
Details of complaint: on 9/21/2018, customer reported that on a few occasions, this gas unit showed it was connected and receiving gas but did not give readings on the connect monitor.Customer biomed had not been able to successfully reproduce the issue.Customer change out the water traps on a "regular basis" and followed the prescribed warm up time.Aux cable was fully connected and checked for bent/broken pins.When nk tech support followed up with customer on 12/27/2018, customer stated to close the ticket.Further information was not provided.Service requested: none.Service performed: none.Investigation result: device was not returned to nk for evaluation and/or repair.Device was put into service on 11/6/2008.Warranty expired on 11/6/2013.Due to no evaluation, and due to the issue could not be successfully duplicated by customer biomed, the root cause could not be determined.Review of the device history record (dhr) shows that the unit has no history of ncmr, refurbishing, or other suspected defects.Investigation conclusion device was not returned to nk for evaluation and/or repair.Device was put into service on 11/6/2008.Warranty expired on 11/6/2013.Due to no evaluation, and due to the issue could not be successfully duplicated by customer biomed, the root cause could not be determined.

• 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: 7982433
• Report Number: 8030229-2018-00407
• Device Sequence Number: 16525394
• Product Code: CCK
• UDI-Device Identifier: 00841983103162
• UDI-Public: 00841983103162
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K020046
• 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): 01/22/2020
• Report Date (Section F): 01/22/2020

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: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/21/2020
• Device Age: 45 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT APPLICABLE
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/22/2020