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

Model Number AG-920RA

Device Problem Device Inoperable (1663)

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

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reports that the multi gas unit receives a gas calibration error while in patient use.The tubing has been checked and the water trap has been replaced.The device has been restarted, how the error still appears.The device was returned for evaluation and repair.The unit was cleaned and evaluated.The reported problem of "gas calibration error" was duplicated.All malfunctioning parts were replaced.The unit was tested per operator's/service manual and the results were recorded on the maintenance check sheet.The unit completed 10 hours of extended testing and operates to manufacturer's specifications.Repaired unit was shipped back to the customer.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reports that the multi gas unit receives a gas calibration error while in patient use.

• Brand Name: AG-920RA
• Type of Device: MULTI-GAS UNIT
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; 1-31-4 nishiochiai, shinjuku-k; attn: shama mooman; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687133
• MDR Report Key: 6350762
• MDR Text Key: 68089767
• Report Number: 8030229-2017-00050
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/22/2017,01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• 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: 02/03/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2017
• Distributor Facility Aware Date: 01/25/2017
• Device Age: 59 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2017
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1