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

Catalog Number 425-00

Device Problem Failure to Sense (1559)

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

Event Date 11/13/2020

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 # 73l200004n) 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.Corrected data:.

Event Description

It was reported that "the device will not detect water when properly set up and is un-useable".The issue was detected prior to use on a patient.No patient involvement.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the back mounting bracket was cracked and one of the strain reliefs was missing on the heated wire cables.No other issues were found.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 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.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.The water reservoir and column were emptied, and the unit was connected again for a functional bench test.The unit ran for approximately 1 hour and the low water indicator light did not come on.The low water reed switch was removed from the bottom of the unit and was found to be corroded.Afterwards, a lab inventory low water reed switch was installed onto the complaint sample and the unit was again connected for a functional bench test with the water reservoir and the column emptied.This time the low water indicator light did come on.Testing confirms the unit had a faulty low water reed switch.The complaint has been confirmed.The investigation revealed a corroded low water reed switch.The root cause for the failure is unintentional user error.The switch can become corroded if an excessive amount of liquid disinfectant is used on the bottom of the neptune.It can also occur if water is allowed to run down the unit and it is not properly dried after use.Teleflex will continue to monitor and trend on complaints of this nature.Corrected data:.

Event Description

It was reported that "the device will not detect water when properly set up and is un-useable".The issue was detected prior to use on a patient.No patient involvement.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 10949468
• MDR Text Key: 219914563
• Report Number: 3003898360-2020-00949
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Date Manufacturer Received: 02/08/2021
• 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
• Treatment: N/A.