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

Catalog Number 425-00

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

User facility reported they were unable to adjust the temperature on the device prior to patient use.

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.It was noted that all the lights on the display functioned properly but the speaker on the unit functioned intermittently.During the temperature display accuracy test the unit displayed the correct temperatures and the proper lights flashed in the high temperature scenario but the unit made no sound.The unit was prepared for the functional bench test where an adult breathing circuit 880-36kit was connected to the returned concha neptune heater.A concha smart 382-10 universal column was placed in the neptune, air supply for the breathing circuit setup was regulated at 10 lpm with a supplied release valve, and water was supplied with a 1650 ml sterile water bottle.The neptune operation parameters were set as follows: patient air was set at 37 c and operation mode was set to invasive.The rain out mode was not able to be adjusted.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed.Since the unit passed the initial power-on tests the power supply pcb is not defective.Since all the lights on the display worked properly, the user interface pcb is not defective.This means the power control pcb is defective.

Event Description

User facility reported they were unable to adjust the temperature on the device prior to patient use.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 10288969
• MDR Text Key: 199255674
• Report Number: 3003898360-2020-00501
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• 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: 07/06/2020
• Date Manufacturer Received: 08/03/2020
• 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