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

Model Number	AG-920RA
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the multi-gas unit is giving incorrect readings that are too low and the unit was unable to be calibrated.No patient harm was reported.Investigation results: could not confirm customer complaint.This unit was warmed up for 30 minutes and calibrated with no issue.This was repeated several times.Never had an issue with the co2 reading low on this unit.Possible root cause may be user error in improper calibration/use of the device.Extent of troubleshooting performed by customer is unknown.Contributing factors to inaccurate/low co2 readings include: (1) incorrect sample line used as use of the unit with a sample line which is not supported may lead to inaccurate readings, or (2) incorrect positioning of the line, which may cause the line to become obstructed with condensation and skew the co2 values.As the sample line and placement was not verified to be correct with the customer, and evaluation was unable to duplicate the problem or find any issues with the device, possible root cause of the incorrect readings is likely due to user error.
Event or Problem Description
The customer reported that the multi-gas unit is giving incorrect readings that are too low and the unit was unable to be calibrated.No consequence or impact to the patient.
Event or Problem Description
The customer reported that the multi-gas unit is giving incorrect readings that are too low and the unit was unable to be calibrated.No consequence or impact to the patient.
Additional Manufacturer Narrative
H10: additional narrative: on (b)(6) 2014, customer reported the multigas unit was giving low co2 reading.Customer was unable to calibrate.Service requested: repair.Service performed: evaluation.Investigation result: nka repair center evaluated the device.The reported issue could not be duplicated.Device was able to calibrate after the warmup time per operator's manual.The reported issue with "low co2 reading" could not be duplicated.Repair report noted no issues with co2 readings.This notification was the first service record for this device.Review of the device history record (dhr) shows that the unit has no history of capa ncmr, refurbishing, or other suspected defects (see dhr review in notification folder).The root cause of the reported issue could not be determined.Corrected information: d10.Device available for evaluation? return date h3.Device evaluated by manufacturer? evaluation summary incorrectly selected.

• 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: 8466343
• Report Number: 8030229-2019-00078
• Device Sequence Number: 13500816
• 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): 07/17/2019
• Report Date (Section F): 07/17/2019

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: 11/04/2014
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/16/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/24/2014
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 07/17/2019
• 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: 07/17/2019