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

Catalog Number 425-00

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

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 #73j200004n) 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

The complaint is reported as: the condensation on the unit could not be controlled during use on a patient.No patient injury or consequence reported.

Event Description

The complaint is reported as: the condensation on the unit could not be controlled during use on a patient.No patient injury or consequence reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no defects observed.Functional testing was performed and the unit was connected to 110vac.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 prepared for the functional bench test where water, an adult breathing circuit (880-36kit), 2-3 lpm of air pressure, and a 382-10 universal 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.The rainout settings were able to be adjusted and the other settings were set to invasive, at 37 degrees c.The unit functioned without any interruption and was able to heat up to 37 degrees c.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.The rainout settings were able to be adjusted and the unit functioned as expected.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 10580066
• MDR Text Key: 208331394
• Report Number: 3003898360-2020-00790
• Device Sequence Number: 1
• Product Code: BTT
• 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: 09/14/2020

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 Catalogue Number: 425-00
• Device Lot Number: 612060305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 10/24/2020
• Supplement Dates FDA Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1