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

Model Number IPN913776

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2021

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.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

It was reported "the second humidifier lost temp, timer, and humidity control".No patient involvement reported.

Event Description

It was reported "the second humidifier lost temp, timer, and humidity control".No patient involvement reported.

Manufacturer Narrative

Qn#: (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed the sample had a crack in the rear mounting bracket.No other defects were observed.Functional testing was performed and the unit was connected to 120vac.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.The unit was then prepared for the functional bench test where water, an adult breathing circuit (880-36kit), air flow, and a 382-10 concha smart column was connected to the unit for a real time operational scenario.In order to replicate the reported defect, an attempt was made to adjust the humidity gradient settings.However, the settings could not be adjusted as the unit was returned in auto settings mode.Auto settings mode is a design feature that allows the user to pre-set the temperature and gradient of the neptune for convenience.While auto settings mode is turned on, the settings may not be adjusted since they have already been pre-set.Once auto settings mode was turned off, the settings were able to be adjusted with no difficulty.The values were set as follows: temperature at 37 c, mode was invasive, and full rainout on the humidity gradient.The unit successfully negotiated all pre-operational self-tests again and was functioning real time.The unit heated up to the set temperature and functioned without any interruption or functional anomalies.The product ifu states: "to activate and deactivate auto settings mode, press and hold the console button for 5 seconds while the unit is in stand-by mode (the unit is off but plugged in).The led display will display the new status of on or off." the complaint cannot be confirmed.Functional testing did not reveal any operational anomalies.The unit was returned in auto settings mode.Once auto settings mode was turned off, the humidity gradient was able to be adjusted with no difficulty.The ifu provides instructions on how to activate and deactivate auto settings mode.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 12342242
• MDR Text Key: 267264492
• Report Number: 3003898360-2021-00686
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 14026704646811
• UDI-Public: 14026704646811
• 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: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN913776
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Date Manufacturer Received: 09/13/2021
• 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: Reuse
• Patient Sequence Number: 1