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

Model Number GF-210RA

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Intermittent Loss of Power (4016)

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

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that his multi gas unit will suddenly stop working.He reports that it will produce gas readings and then will suddenly stop giving a reading.He has tried replacing the water trap and sample lines, but the issue still persists.Nihon kohden technical support verified that the unit was powered on for at least an hour before putting it on patient use.The unit was sent in to be evaluated.Upon completion of the evaluation it was determined that the problem of "gas unit will stop working" could not be duplicated through testing, troubleshooting and 3 days extended operation of the device.Review of the device history indicates no previous "could not duplicate" status.The unit was tested per operator's/service manual and operates to manufacturer's specifications.

Event Description

The biomedical engineer (bme) reported that his multi gas unit will suddenly stop working.

Manufacturer Narrative

Details of complaint on (b)(6) 2017, customer stated that the gas unit will stop working suddenly.The gas reading was intermittent, gave gas readings and then just stop.Customer had replaced water trap, sampling lines but the issue remained.Customer had allowed adequate warm up time.No error messages were reported.Service requested: repair/ loaner.Service performed: evaluation.Investigation result: gas unit was evaluated at nka repair center.The reported issue could not be duplicated through extensive testing.Customer was advised to transition to the new sampling line part#: a/8290286.Per technical bulletin mmbex 052 issued to customers on (b)(6) 2017, sampling yg-610p was no longer being offered due to manufacturer's change in the water trap.Customer could continue using the older yg-610p during this transition.If the device experience message to "check water trap", it is indication to replace the sampling line.In the current ticket, customer reported no error messages.The reported issue could not be duplicated through extensive testing at nka.Service history for this device shows no other related issues.Without knowing more about customer's set up, operating environment, it is not possible to determine the root cause of the reported issue.Additional information: correction: f9.Approximate age of device: incorrectly calculated.Additional information: b4.Date of this report.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? additional information.Correction.Device evaluation.H3.Device evaluated by manufacturer? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that his multi gas unit will suddenly stop working.

• Brand Name: GF-210RA
• 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: 7199930
• MDR Text Key: 97790996
• Report Number: 8030229-2018-00013
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: 4931921106891
• Combination Product (y/n): N
• PMA/PMN Number: K110594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• 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
• 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: 10/11/2019
• Distributor Facility Aware Date: 10/03/2019
• Device Age: 47 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2019
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1