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

Model Number AG-920RA

Device Problems Failure to Sense (1559); Device Operational Issue (2914)

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

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

Corrected data : device evaluated by manufacturer. Additional manufacturer narrative: the customer reported that the multi gas unit stopped producing gas readings while in the middle of a case. The readings would come back if the glass was tapped. No patient harm was reported. The customer has sent the unit in for evaluation. The unit was cleaned and evaluated. The reported problem of "gas measurement is dropping off" was duplicated. All malfunctioning parts were replaced. The unit was tested per the operator's/service manual and completed 24 hours of extended testing. The unit operates to manufacturer's specifications and has been sent back to the customer.

Manufacturer Narrative

The customer reported that the multi gas unit stopped producing gas readings while in the middle of a case. The readings would come back if the glass was tapped. No patient harm was reported. They sent the device in for repair and it is currently 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 if additional information becomes available.

Event Description

The customer reported that the multi gas unit stopped producing gas readings while in the middle of a case. The readings would come back if the glass was tapped.

• 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: 7162921
• MDR Text Key: 286925431
• Report Number: 8030229-2018-00002
• Device Sequence Number: 1
• Product Code: CCK
• 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,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 12/27/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2019
• Distributor Facility Aware Date: 10/03/2019
• Device Age: 101 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2019
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE