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

Model Number	AG-920RA
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the readings on the multi gas unit are fluctuating when in patient use.The water trap and sampling line was changed; however the issue still exists.Customer sent the device in for evaluation and repair.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 readings on the multi gas unit are fluctuating when in patient use.
Additional Manufacturer Narrative
Details of complaint on (b)(6) 2018 customer reported that gas readings were fluctuating while in use.Service requested: repair.Service performed: repair.Investigation result: 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.Particularly, how often the water trap, sampling line, and water trap receptacles are replaced to ensure accuracy and proper functioning of the gas sensor.Nka repair center evaluated the device and recommended replacing cd-237p gas unit sensor to resolve the issue.When repair services completed replacing the sensor, the issue was resolved.Device operated to manufacturer's specification.Device was put into service on 7/21/2011.Service history for this device shows this is an isolated incident.As maintenance and usage information for the gas unit is not available, the root cause for the failed sensor cd-237p could not be determined.Device functioned as intended past the five-year warranty period.Review of the device history record (dhr) shows that the unit has no history of ncmr, refurbishing, or other suspected defects.Corrected data: d4: udi#: incorrectly listed on mdr initial.Additional information: b4.Date of this report.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? additional information.Correction.Device evaluation.H3.Device evaluated by manufacturer? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.
Event or Problem Description
The customer reported that the readings on the multi gas unit are fluctuating when 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: 7770901
• Report Number: 8030229-2018-00307
• Device Sequence Number: 11201987
• 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: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019
• Report Date (Section F): 10/22/2019

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: 08/06/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/21/2019
• Device Age: 91 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 10/22/2019
• 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: 10/22/2019