MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION GF-210RA; MULTI-GAS UNIT

Model Number GF-210RA

Device Problem Device Inoperable (1663)

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

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reports that the multi gas unit receives a gas calibration error and was not functioning as it should.The sample lines and water trap were both changes, however this did not resolve the issue.The device was powered on and warmed before it was in patient use.No patient harm was reported.The unit was cleaned and evaluated.The reported problem was duplicated.Unit did not recognize known good water traps.The gas sensing unit was replaced on this unit.The unit was tested per the operator's/service manual and the results were recorded on the maintenance check sheet.The unit was tested and operates to manufacturer's specifications.Repaired unit was returned to the customer.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 reports that the multi gas unit receives a gas calibration error and was not functioning as it should.The sample lines and water trap were both changes, however this did not resolve the issue.The device was powered on and warmed before it was in patient use.No patient harm was reported.

• Brand Name: GF-210RA
• Type of Device: MULTI-GAS UNIT
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer Contact: susan shadley ; 1-31-4 nishiochiai, shinjuku-k; attn: susan shadley; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687133
• MDR Report Key: 6291485
• MDR Text Key: 66217580
• Report Number: 8030229-2017-00015
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: 4931921106891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110594
• 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: 01/31/2017,01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-210RA
• Device Catalogue Number: GF-210RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2017
• Distributor Facility Aware Date: 01/06/2017
• Device Age: 61 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2017
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2011
• 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