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

Model Number IPN913776

Device Problem Device Emits Odor (1425)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that the unit "smells of smoke".No patient involvement reported.

Manufacturer Narrative

(b)(4), the sample was returned for evaluation.A visual exam was performed and the trim ring was found to be cracked.No other defects were observed.Functional testing was performed and the unit was connected to 120vac.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.No odor was noted.The unit was prepared for the functional bench test where a water reservoir bottle, an adult breathing circuit (880-36kit), a 382-10 conchasmart column, and dual temperature probes were connected to the unit.Air flow was supplied to the unit for a real time operational scenario.The unit successfully navigated 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 or functional anomalies for ~1.0 hour.No unexpected odors were noted.A device history record review was performed and no relevant findings were identified.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 that the unit "smells of smoke".No patient involvement reported.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 11900822
• MDR Text Key: 253145454
• Report Number: 3003898360-2021-00532
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• 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: 06/07/2021
• Date Manufacturer Received: 07/09/2021
• 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