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	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit was returned for evaluation.The unit was cleaned and evaluated.The reported problem was duplicated.When tested, the gas unit giving off a noise and displayed a change water trap alarm.The gas sensor and water trap receptacle dry line was replaced.All steps of the maintenance check sheet were tested and completed per the service manual.The unit completed 3 days of extended testing and operates to manufacturers' specification.
Event or Problem Description
The customer reports that the multi gas unit is not taking an accurate reading.The device is running louder than usual and giving a calibration error when connected to the bedside monitor.
Event or Problem Description
The customer reports that the multi gas unit is not taking an accurate reading.The device is running louder than usual and giving a calibration error when connected to the bedside monitor.
Additional Manufacturer Narrative
Details of complaint on 7/18/2018 customer stated that gas unit was not taking accurate reading, running louder than usual, and has a calibration error when connected to a bsm.Nka repair center evaluated the device.Gas unit was observed to be making a humming noise, as well as displaying a message to replace water trap.Gas sensor, cd-237p, as well as regular maintenance items (water trap and disposable sampling line) were recommended to be replaced.Customer opted to buy a replacement unit, rather than repair the current one.Service requested: evaluation.Service performed: evaluation.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.Device was put into service on 10/24/2012.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.Additional information: if follow-up, what type? additional information.

• 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: 7789700
• Report Number: 8030229-2018-00321
• Device Sequence Number: 13774889
• Product Code: CCK
• UDI-Device Identifier: 00841983103162
• UDI-Public: 00841983103162
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 08/13/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/22/2019
• Device Age: 72 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 08/16/2018
• 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