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

Catalog Number 425-00

Device Problem Insufficient Heating (1287)

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "staff advised that the unit is not working properly.It will not heat up." the issue was detected prior to use.No patient involvement.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.Upon receipt the unit was visually inspected for outward, visible signs of misuse/abuse/neglect.Nothing of any significance was noted in terms of physical damage.The unit was inspected for cracks, wire frays, plastic case cracks/fractures, burn areas/wires, damaged power cord strain reliefs, and nothing was noted.No significant amount of lint built up on fan or cooling ports.The unit was gently rotated and then lightly shaken to determine if any loose components might be moving around inside the plastic case.Nothing loose was noted.The neptune was then connected to 110 vac.The unit passed the initial power connect test.The unit also navigated through the power-on self-test (p.O.S.T.) with no issues.The next test was the temperature display accuracy test.The neptune 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), 10 lpm of air pressure, and a 382-10 concha smart water column was connected to the unit for a real time operational scenario.Temperature was set at 37 c, mode was invasive, full rainout on the moisture scale.The concha smart column was placed into the neptune before the bench test was started.The neptune was turned on, values set.The column was empty.The neptune low water indicator lamp came on.Water was added to the column.The unit successfully negotiated all pre-operational self-tests again and was functioning real time.The unit functioned without any interruption or functional anomalies for ~2.5 hours.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.There were no issues found with the returned device.

Event Description

The complaint is reported as: "staff advised that the unit is not working properly.It will not heat up." the issue was detected prior to use.No patient involvement.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9528299
• MDR Text Key: 174510742
• Report Number: 3003898360-2019-01481
• 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: 12/03/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/28/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.