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

Model Number IPN913776

Device Problem Power Problem (3010)

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

Event Date 01/26/2021

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 that the unit "is shutting down".No patient involvement reported.

Event Description

It was reported that the unit "is shutting down".No patient involvement reported.

Manufacturer Narrative

Qn#(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 a full functional bench test in attempt to replicate the reported defect.A water reservoir bottle, an adult breathing circuit (880-36kit), a 382-10 conchasmart column, and dual temperature probes were connected to the unit.2-3 lpm of air flow were supplied to the unit for a real time operational scenario.The settings were set to full rainout, invasive, at 37 degrees c.The unit shut off during the test.The unit was opened and the power supply board was replaced with a known good lab inventory power supply board.This time, the unit successfully navigated all pre-operational self-tests again and was functioning in real time.The unit functioned without any interruption and was able to heat up to the set temperature of 37 degrees c with the lab inventory power supply board.Testing confirms the unit had a faulty power supply board.The complaint has been confirmed.The investigation revealed a defective power supply board.The root cause for the failure is unknown.The power supply board may have encountered higher stresses than normal causing it to fail before its intended use life.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: 11342775
• MDR Text Key: 232380292
• Report Number: 3003898360-2021-00129
• 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: 01/28/2021

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: 02/15/2021
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 03/19/2021
• 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
• Treatment: N/A.