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

Catalog Number 425-00

Device Problem Insufficient Heating (1287)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reports the heater is not reaching the set temperature and shuts off.The issue was detected during patient use.No patient harm was reported.The patient's condition is reported as fine.

Event Description

Customer reports the heater is not reaching the set temperature and shuts off.The issue was detected during patient use.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the housing was cracked on the bottom right side of the device.The plastic wing brackets on the left and right side of the neptune were also damaged.These are cosmetic issues which do not affect the functionality of the device.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.In addition to the named test parameters, the neptune operational values were set as follows: temperature was set at 37 c, mode was invasive, full rainout on the moisture scale.The neptune was turned on, values set.The unit successfully negotiated all pre-operational self-tests again and was functioning real time.The unit heated up to the set temperature and functioned without any interruption or functional anomalies.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 10806353
• MDR Text Key: 215289074
• Report Number: 3003898360-2020-00885
• 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: 10/16/2020

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: 10/23/2020
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/08/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/07/2020
• 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
• Treatment: NONE REPORTED.; NONE REPORTED.