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

Model Number IPN913776

Device Problem Failure to Select Signal (1582)

Patient Problem Insufficient Information (4580)

Event Date 04/02/2021

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 # 73d210006n) at the manufacturing facility and were functionally tested.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

It was reported the unit "will not switch to invasive".Unknown where alleged issue was found at time of report.Unknown patient condition at time of report.

Event Description

It was reported the unit "will not switch to invasive." additional information received indicates the issue was detected prior to use on a patient.

Manufacturer Narrative

(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.When an attempt was made to change modes, the "accept" button did not illuminate.The unit still functioned properly and was able to change modes, but the button did not illuminate on the user interface panel.The unit was prepared for the functional bench test where water, an adult breathing circuit (880-36kit), 2-3 lpm of air pressure, dual temperature probes, and a 382-10 concha smart water column was connected to the unit for a real time operational scenario.The unit successfully negotiated all pre-operational self-tests again and was functioning in real time.All settings could be adjusted on the unit with no issues.The "accept" button still did not illuminate.The complaint of not being able to change the settings could not be confirmed.However, during functional testing the "accept" button on the user interface panel was found to not illuminate.The button was still able to function and the modes could be changed on the unit.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 and 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 the light failure.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: 11723402
• MDR Text Key: 247266025
• Report Number: 3003898360-2021-00418
• 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: 04/02/2021

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: 04/23/2021
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 05/18/2021
• Supplement Dates FDA Received: 05/19/2021
• 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