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

Model Number AG-920RA

Device Problems Gas Output Problem (1266); No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multi-gas unit failed during patient monitoring.The device displayed error messages of, "check water trap and sample line" and "check external unit." no patient harm was reported.The device has been returned to nihon kohden and is awaiting evaluation.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 the multi-gas unit failed during patient monitoring.The device displayed error messages such as, "check water trap and sample line" and "check external unit." no patient harm was reported.

Event Description

The customer reported that the multi-gas unit failed during patient monitoring.The device displayed error messages such as, "check water trap and sample line" and "check external unit." no patient harm was reported.

Manufacturer Narrative

Details of complaint: on 10/17/2019 customer stated that gas device was displaying error message for checking water trap and sampling line, even after replacing these parts.Device was sent to nka for evaluation and repair.Nka repair center evaluated the device."change water trap" message was observed.Technician was unable to calibrate gas.The following part needed replacement: 1-part# cd-237p description: gas module.Service requested: evaluation and repair.Service performed: replaced 1-part# cd-237p description: gas module.Investigation conclusion: 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.Nka repair center evaluated the device and recommended replacing cd-237p gas unit sensor to resolve the issue.When repair services completed replacing the sensor, the issue was resolved.Device operated to manufacturer's specification.Device was put into service on (b)(6) 2012.The root cause of the sensor failure is unknown, however it operated as intended past the five-year warranty period for this device.

• 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: 9307259
• MDR Text Key: 200626286
• Report Number: 8030229-2019-00639
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2020
• Distributor Facility Aware Date: 03/16/2020
• Device Age: 86 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2020
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1