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

Model Number AG-920RA

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their multi-gas unit was displaying low co2 readings during a case.The customer also reported that the unit went through self calibration after which the readings were low.They replaced the dry line water trap, as well as the sampling line, but the issue persisted.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 Description

The customer reported that their multi-gas unit was displaying low co2 readings during a case.

Manufacturer Narrative

Details of the complaint: on 11/21/2019, customer at (b)(6) health center reported the gas unit (ag-920ra sn: (b)(6)) had low co2 readings.The issue would occur after the device goes through a self calibration.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.

Event Description

The customer reported that their multi-gas unit was displaying low co2 readings during a case.

• Brand Name: AG-920RA
• Type of Device: 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: 9470248
• MDR Text Key: 200822663
• Report Number: 8030229-2019-00723
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 00841983103162
• UDI-Public: 00841983103162
• Combination Product (y/n): N
• PMA/PMN Number: K020046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 03/04/2020
• Distributor Facility Aware Date: 03/03/2020
• Device Age: 88 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2020
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1