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

Model Number	AG-920RA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the multi-gas unit gave a "gas cal" error message during a case.The customer also reported that the unit experienced severe drop in etco2 readings.No patient harm or injury was reported.The customer would like to send the unit in for a repair.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.Additional model information: the following bsm was used in conjunction with the multi-gas unit but did not experience failure.Attempts to obtain information on the device were made, but not provided: bsm: model: mu-6701ra, s/n: ni, approximate age of the device: ni.No serial number was provided, so the age of the device is unknown, device manufacturer date: ni, unique identifier (udi) #: (b)(4).
Event or Problem Description
The customer reported that the multi-gas unit gave a "gas cal" error message during a case.
Event or Problem Description
The customer reported that the multi-gas unit gave a "gas cal" error message during a case.
Additional Manufacturer Narrative
Details of the complaint.On (b)(6) 2019, customer at (b)(6) reported the device experienced a significant drop in etco2 readings and after changing out the gas monitor (ag-920ra sn: (b)(6) ), they received a gas calibration error.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 model information: d11 & c2: the following bsm was used in conjunction with the multi-gas unit but did not experience failure.Attempts to obtain information on the device were made, but not provided: bsm - model: mu-6701ra.S/n: ni.Approximate age of the device: ni.No serial number was provided, so the age of the device is unknown.Device manufacturer date: ni.Unique identifier (udi) #: (b)(4).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: 9470247
• Report Number: 8030229-2019-00721
• Device Sequence Number: 2966231
• 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
• 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: 11/20/2019
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 12/13/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BSM.; BSM.
• Date Report Sent to FDA: 03/04/2020