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

Model Number GF-210RA

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Stops Intermittently (1599); Device Inoperable (1663); Device Operates Differently Than Expected (2913)

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

Event Date 12/21/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reports that they are having intermittent problems with the endtidal co2 readings on the multi gas unit.It does not work consistently.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 they are having intermittent problems with the endtidal co2 readings on the multi gas unit.It does not work consistently.

Manufacturer Narrative

The customer originally reported that the multigas unit just stopped working and shut down on its own.It was later reported that this unit had intermittent issues with the end tidal co2 readings and was not working consistently.There was no sign of physical damage or fluid intrusion and the unit was sent to nihon kohden for evaluation and repair.The unit was cleaned and evaluated.The reported issues could not be duplicated.Nihon kohden performed an air calibration and tested the gas functions, however no issues were found.The unit was tested per the service manual and the results were recorded on the maintenance check sheet.The unit completed 10 days of extended testing, never shut down during this period of time, and operates to manufacturer's specifications.The multigas unit was then 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 if additional information becomes available.

• 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: 6268837
• MDR Text Key: 65707006
• Report Number: 8030229-2017-00006
• 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,Followup
• Report Date: 01/20/2017,12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• 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: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2017
• Distributor Facility Aware Date: 12/21/2016
• Device Age: 51 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2017
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2012
• 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