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

(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

(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 a red wrench symbol.The unit was opened and significant amounts of dust/lint were observed on the power supply board.The power supply board was replaced with a known good lab inventory power supply board but a red wrench still displayed.The power control board was inspected for signs of damage such as fried circuits or melted components.No damage was noted.The wires, wire harnesses and connectors were inspected and no damages were observed.The resistance across the thermal fuse and thermal switch were measured to be 0.2 ohms, which is in within the range of 0.2-0.4 ohms as it should be.The resistance of p1h104t thermistor included in the harness was measured to be 105 ohms which is within the normal range at room temperature.There were no issues with the power supply board and user interface board and a failure of either board would not cause a red wrench.There were no defects observed on any of the internal components.By process of elimination, the unit has a faulty power control board.The complaint has been confirmed.The investigation revealed a defective power control board.A device history record review was performed with no evidence to suggest a manufacturing related cause.Each neptune device is inspected 100% during manufacturing assembly, it is unlikely this defect was present at the time of release.The root cause for the failure is normal wear.The unit was manufactured in 2013 and the device was designed for a minimum of 5 years.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: 10569864
• MDR Text Key: 208109839
• Report Number: 3003898360-2020-00774
• 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
• Treatment: N/A.; N/A.