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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the multi-gas unit is not giving accurate readings.The customer tried replacing the water trap, sampling line, and also performed calibration; however, the device still gives inaccurate readings.The customer stated they will return the device for evaluation.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 customer reported that the multi-gas unit is not giving accurate readings.The customer tried replacing the water trap, sampling line, and also performed calibration; however, the device still gives inaccurate readings.The customer stated they will return the device for evaluation.
Event or Problem Description
The customer reported that the multi-gas unit is not giving accurate readings.The customer tried replacing the water trap, sampling line, and also performed calibration; however, the device still gives inaccurate readings.The customer stated they will return the device for evaluation.
Additional Manufacturer Narrative
Details of complaint: on (b)(6) 2018 customer reported gas unit ag-920ra s/n (b)(6) was giving inaccurate readings.Customer had tried replacing the water trap, sampling line, and also calibration but it still gives inaccurate readings.Customer requested repair services.Service requested: evaluation and repair.Service performed: evaluation: unit was cleaned and under evaluation.We also visually inspected the labels that matched with the unit.The reported problem "gas unit was not giving an accurate of gas readings" was duplicated.We connected gas with the bedside and tested the gas readings.The gas unit was providing very low reading on co2.Recommend replacing gas sensor unit cd-237p gas unit, ag-920ra 1 ea customer decided to continue with the recommended repairs.Investigation result: device was put into service on 4/17/2003.Service history shows no other notifications.Operator's manual revision j stated that gas calibration should be performed yearly for stable measuring accuracy.When the accuracy is not appropriate, perform gas calibration.The maintenance history for this device is unknown.Maintenance of the device consists of periodic checks, regularly changing water trap as specified, and replacing sampling line after each use.Failure to perform the required maintenance could affect device functionality.Device maintenance history was not provided.The root cause of the sensor unit failure could not be determined.Review of the device history record (dhr) shows that the unit has no history of capa, ncmr, refurbishing, or other suspected defects (see attached).Investigation conclusion: device maintenance history was not provided.The root cause of the sensor unit failure 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: 7866456
• Report Number: 8030229-2018-00360
• Device Sequence Number: 2013109
• Product Code: CCK
• UDI-Device Identifier: 00841983103162
• UDI-Public: 00841983103162
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/09/2020
• Report Date (Section F): 01/09/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/08/2020
• Device Age: 187 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 01/09/2020
• 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: 01/09/2020