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

Model Number IPN913776

Device Problem Failure to Power Up (1476)

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

Event Date 08/23/2021

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 unit is "not powering on".No patient involvement reported.

Manufacturer Narrative

Qn #(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the plastic wings above the right and left plastic wing brackets were broken.No other defects were observed.Functional testing was performed and the unit was connected to 120vac.The unit passed the initial power connect test however the power button did not strobe.The unit was not able to navigate through the power-on self-test (p.O.S.T.).The unit was opened and the power supply board (11823) was replaced with a known good lab inventory board.This time the unit was able to navigate through the power-on self-test (p.O.S.T.) with no issues.The complaint has been confirmed.The investigation revealed a defective power supply board.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.The unit was manufactured in 2010 and was designed for a minimum of 5 years.The root cause for the failure is normal wear.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported the unit is "not powering on".No patient involvement reported.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 12477793
• MDR Text Key: 271674951
• Report Number: 3003898360-2021-00824
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• 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: 09/07/2021
• Date Manufacturer Received: 09/30/2021
• 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