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

Model Number	AG-920RA
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the multigas unit displayed "calibration" error while in patient use.The customer also reported that the etco2 and o2 reading were low.They replaced the dry line water trap 2 days prior to this event and they allowed the device to warm up for approximately 1 hour before use.They would like to send the unit in for a repair.There was no harm or injury reported.Nihon kohden continues to investigate the reported event.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 multigas unit displayed "calibration" error while in patient use.
Event or Problem Description
The customer reported that the multigas unit displayed "calibration" error while in patient use.
Additional Manufacturer Narrative
Details of the complaint: on (b)(6) 2019, customer at st.Vincent health center reported the gas unit (ag-920ra sn: (b)(6) was receiving a calibration error when they were trying to calibrate it.The etco2 and o2 were reported to be low.The error was reported to occur during the case.Investigation summary: as the reported issue could not be reproduced at nka, the root cause could not be determined.Risk analysis was not conducted as evaluation of the unit at nka did not identify a non-conformance.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? h3 device evaluated by manufacturer? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

• 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: 9419823
• Report Number: 8030229-2019-00705
• Device Sequence Number: 19439010
• Product Code: CCK
• UDI-Device Identifier: 00841983103162
• UDI-Public: 00841983103162
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K020046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020
• Report Date (Section F): 03/04/2020

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: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/03/2020
• Device Age: 88 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/04/2020