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

Model Number IPN913776

Device Problem Failure to Read Input Signal (1581)

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

Event Date 07/06/2021

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 unit "won't allow adjustment of the humidity level".No patient involvement reported.

Manufacturer Narrative

Qn#: (b)(4).The sample was returned for evaluation.A visual exam was performed and there were no major defects 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.However, it was noted that the speaker was not producing any sound.The unit was then prepared for the functional bench test where a water reservoir bottle, an adult breathing circuit (880-36kit), a 382-10 conchasmart column, and dual temperature probes were connected to the unit.Air flow was supplied to the unit for a real time operational scenario.When attempting to change the settings, it was noted that the humidity settings were not illuminating and therefore not able to be changed, despite the unit being connected to heated wire circuits as instructed in the user manual.The unit was opened, and the power supply board was replaced with a known good lab inventory board, resulting in no change.The humidity setting icons illuminated during power-on, eliminating the user interface board as a potential faulty component.It was noted that the harness was clearly burnt at the orange connector, which corresponds to the 24v power supply to the unit.This harness was replaced with a known good lab inventory harness, and the speaker was fixed.Testing confirms the unit had a faulty harness.It is likely that the harness disrupted current flow to the rest of the unit, contributing to or causing the failure of both the speaker and the humidity settings.The complaint has been confirmed.The investigation revealed a defective harness.Since the neptunes are 100% functionally tested during manufacturing assembly, it is unlikely that the failure was present at the time of release.A device history record review was performed with no evidence to suggest a manufacturing related issue.It is possible the unit encountered excessive stresses while in use, causing it to fail prematurely.The root cause for the failure is unknown.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported the unit "won't allow adjustment of the humidity level".No patient involvement reported.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 12245876
• MDR Text Key: 264080162
• Report Number: 3003898360-2021-00628
• 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: 07/07/2021

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 Model Number: IPN913776
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 08/31/2021
• 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