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

Catalog Number 425-00

Device Problem Overheating of Device (1437)

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

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the "heater temperature was reading 42 [celcius]".No patient injury reported.It was reported heater and circuit were replaced immediately.Patient condition reported to be fine.

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 settings were set to full rainout, invasive, at max temperature of 40 degrees c.The unit functioned without any interruption or functional anomalies for ~1.0 hour.The unit did not overheat and did not alarm.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.

Event Description

It was reported the "heater temperature was reading 42 [celsius]".No patient injury reported.It was reported heater and circuit were replaced immediately.Patient condition reported to be fine.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 11142966
• MDR Text Key: 226071804
• Report Number: 3003898360-2021-00038
• 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: 12/17/2020

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/04/2021
• 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