MAUDE Adverse Event Report: HUDSON CONCHA NEPTUNE; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 425-00

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.A verification of failure mode reported in the current manufacturing process was conducted as follows: 13 devices were taken from the current production, the samples were functionally inspected, and during the test issue reported was not observed in the current manufacturing process.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Customer reported humidity gradient won't come on during use.No patient harm reported.Patient's condition reported as fine.

Event Description

Customer reported humidity gradient won't come on during use.No patient harm reported.Patient's condition reported as fine.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no defects observed.Functional testing was performed and the unit was connected to 110vac.The unit passed the initial power connect test and navigated through the power-on self-test (p.O.S.T.) with no issues.During the temperature display accuracy test the unit displayed the correct temperatures and properly alarmed in the high temperature scenario.Due to the nature of the complaint, the concha neptune was prepared for full bench functional testing.A lab inventory adult breathing circuit 880-36kit was connected to the returned concha neptune heater.A concha smart 382-10 universal column was placed in the neptune.Air supply for the breathing circuit setup was regulated at 2-3 lpm (liters per minute) with a pressure relief valve.Water was supplied with a 1650 ml sterile water bottle.The temperature and humidity settings were able to be adjusted.The ifu for this product provides step by step instructions for turning on and turning off "auto settings mode." the ifu states the following: "the auto settings mode is a convenience feature that allows you to pre-set the temperature and gradient of the neptune while still allowing for invasive and non-invasive toggling." "while the unit is in stand-by mode (the unit is off but plugged in) , press and hold the console button for 5 seconds.The led display will display the new status.'on' or 'off'." the complaint cannot be confirmed.Functional testing did not reveal any operational anomalies.The temperature and humidity settings were able to be adjusted.The device is designed with a convenience feature called "auto settings mode" which allows you to pre-set the temperature and gradient of the neptune while still allowing for invasive and non-invasive toggling.The ifu provides step by step instructions for turning on and turning off "auto settings mode.".

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 10465228
• MDR Text Key: 204713574
• Report Number: 3003898360-2020-00704
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K131912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED; NONE REPORTED