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 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reports that the carbon dioxide readings on the multi gas unit works intermittently.No patient harm was reported.The unit was cleaned and evaluated.The reported problem could not be duplicated through testing, trouble shooting, and extended operation of the device.Review of the device history indicates no previous cannot duplicate status.The unit was tested per the operator's manual and the results were recorded on the maintenance check sheet.The unit operates to manufacturer's specification.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 reports that the carbon dioxide readings on the multi gas unit works intermittently.No patient harm was reported.Customer would like to send unit in for evaluation and repair.

• 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: 6127133
• MDR Text Key: 60869877
• Report Number: 8030229-2016-00544
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: 04931921106891
• 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: 11/24/2016,10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2016
• 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: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/24/2016
• Distributor Facility Aware Date: 10/26/2016
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2016
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• 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