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

Model Number AG-920RA

Device Problems Device Stops Intermittently (1599); Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multi gas unit was in use on a patient when the readings suddenly stopped.He stated that the unit would warm up and give a calibration error.The customer switched out the unit with spare multi gas unit to continue patient care.Nihon kohden technical support provided the customer with troubleshooting tips including letting the unit warm up before going into the calibration settings, but the issue persisted.There was no patient harm reported.The customer requested a loaner and sent the device in to nihon kohden for evaluation.The reported problem of "cal error" was duplicated.The gas sensing unit was replaced to resolve the issue.The unit completed 3 days of extended testing and operates to manufacturer's specifications.

Event Description

The customer reported that the multi gas unit was in use on a patient when the readings suddenly stopped.He stated that the unit would warm up and give a calibration error.

Manufacturer Narrative

Details of complaint: on (b)(6) 2018 customer stated device warms up and shows a "cal error" message.Nk tech support instructed customer perform gas calibration.Customer then send the device to nka for evaluation and repair.Nka repair center duplicated the error.Cd-237p gas sensor unit was replaced to resolve the issue.Service requested: repair.Service performed: repair.Investigation result: 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 7/11/2012.Service history shows one other service incident prior to the current record: 300110360.Under this notification, reported on 1/18/2018, customer requested calibration gas part# for preventative maintenance.As maintenance and usage information for the gas unit is not available, the root cause for the failed sensor cd-237p could not be determined.Device functioned as intended past the five-year warranty period.A review of manufacturer's device history record shows no nonconforming report, no deviation and no corrective and preventative actions associated with this device.Corrected data: d4.Udi#: incorrectly listed on mdr initial.Additional information: b4.Date of this report.E2-3.Initial reporter - occupation.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? additional information.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

The customer reported that the multi gas unit was in use on a patient when the readings suddenly stopped.He stated that the unit would warm up and give a calibration error.

• 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: 7340079
• MDR Text Key: 102450814
• Report Number: 8030229-2018-00068
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• 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: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2019
• Distributor Facility Aware Date: 10/21/2019
• Device Age: 73 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2019
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1