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

Model Number IPN913776

Device Problem Failure to Select Signal (1582)

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

Event Date 03/23/2021

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 "customer unable to change gradient setting; gradient settings not functioning; customer states that when accessing menu the gradient settings and blue dot are not illuminated.Verified with customer that multiple conchasmart circuits were plugged into blue pigtail and temperature probes were also connected.Verified with customer that auto setting mode was deactivated.Troubleshooting by phone did not fix the issue".New deviced used.No patient harm or injury reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn#: (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed one of the rear mounting brackets was cracked.No other defects were 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.The unit was able to power on and off with no issues.The unit was the 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.When an attempt was made to adjust the gradient, the gradient lights did not illuminate.Upon disassembly, the heated wire harness was found to have damaged wires.The wires were severed where the harness connects to the power control board.Based on the investigation performed, the reported complaint was confirmed.The investigation revealed that the heated wire harness had damaged wires where it connects to the power control 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.It was determined that unintentional user error caused or contributed to this event.

Event Description

It was reported "customer unable to change gradient setting; gradient settings not functioning; customer states that when accessing menu the gradientsettings and blue dot are not illuminated.Verified with customer that multiple conchasmart circuits were plugged into blue pigtail and temperature probes were also connected.Verified with customer that auto setting mode was deactivated.Troubleshooting by phone did not fix the issue".New device used.No patient harm or injury reported.Patient condition reported as "fine".

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 11641210
• MDR Text Key: 244639502
• Report Number: 3003898360-2021-00345
• 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: 03/24/2021

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: 04/05/2021
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 05/12/2021
• 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