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

Model Number	IPN913776
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional 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 13 devices were taken from current production (425-00 concha neptune lot # 73h210002r) at the manufacturing facility and were inspected.During the test, issue reported "cannot adjust temperature prior to use" was not observed in the current manufacturing process.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 or Problem Description
It was reported "unable to adjust temperature.Heater alarms then resets once it reaches 29 degree celsius".No patient involvement reported.
Additional 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; however, the device would not turn on.The power supply board was bypassed with a known good lab inventory board and this time, the unit 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 prepared for a full functional bench test with the known good power supply board in attempt to replicate the reported defect.A water reservoir bottle, an adult breathing circuit (880-36kit), a 382-10 conchasmart column, airflow, and dual temperature probes were connected to the unit.The unit successfully navigated all pre-operational self-tests again and was functioning in real time.All settings , including temperature, were able to be adjusted on the unit.The settings were set to full rainout, invasive, at 37 degrees c.The unit functioned without any interruption and was able to heat up to the set temperature of 37 degrees c with no issues.Functional testing revealed that the unit had a defective power supply pcba.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 2012 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 this event.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "unable to adjust temperature.Heater alarms then resets once it reaches 29 degree celsius".No patient involvement reported.

• Brand Name: HUDSON CONCHA NEPTUNE
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12656264
• Report Number: 3003898360-2021-00957
• Device Sequence Number: 1207698
• Product Code: BTT
• UDI-Device Identifier: 14026704646811
• UDI-Public: 14026704646811
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K131912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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 Model Number: IPN913776
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown