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

Catalog Number 425-00

Device Problem Insufficient Heating (1287)

Patient Problem No Information (3190)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of the reported failure mode was conducted and 8 devices were taken from current production (425-00 concha neptune lot #73j200004n) at the manufacturing facility, and were functionally inspected.No issues were encountered during the functional testing.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

The complaint is reported as: the neptune is not heating.It unknown when the issue occurred.

Event Description

The complaint is reported as: the neptune is not heating.It unknown when the issue occurred.

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.The unit was prepared for the functional bench test where water, an adult breathing circuit (880-36kit), 2-3 lpm of air pressure, and a 382-10 concha smart water column was connected to the unit for a real time operational scenario.The neptune would not turn on.The unit was opened and significant amount of dust/lint was observed on the power supply board assembly (pcba).It was observed that the connector for wire harness was damaged and showed evidence of overheating.The sample pcba was replaced with a lab inventory pcba and this time , the device was able to turn on.The neptune operational values were set as follows: temperature was set at 37 c, mode was invasive, full rainout on the moisture scale.The unit successfully negotiated all pre-operational self-tests again and was functioning real time.The unit reached the set temperature and functioned without any interruption or functional anomalies.The cause of the failure is due to a faulty power supply board.The reported complaint of "unit is not heating" is confirmed.The sample was returned with a defective power supply pcba.A device history record review was performed with no evidence to suggest a manufacturing related issue.Each concha neptune device is inspected 100% during manufacturing assembly, it is unlikely that this defect was present at the time of release.The sample was manufactured in 2008.The device was designed for a minimum of 5 years.Based on the information available, it appears that unintentional user error - normal wear caused or contributed to this event.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: 10569968
• MDR Text Key: 208024692
• Report Number: 3003898360-2020-00772
• 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: 09/11/2020

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: 09/22/2020
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/02/2020
• 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