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

Catalog Number 425-00

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no defects observed.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 noted.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), 10 lpm of air pressure, and a 382-10 universal water column is connected to the unit for a real time operational scenario.The unit functioned without any interruption or functional anomalies for ~3.0 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.Functional testing did not reveal any operational anomalies.

Event Description

The complaint is reported as: "heaters sent back due to heated wire circuits burning." there was no patient injury/harm reported.

Event Description

The complaint is reported as: "heaters sent back due to heated wire circuits burning." there was no patient injury/harm reported.

Manufacturer Narrative

Qn#(b)(4).Corrected data: section corrected to "no".Section device code corrected to (b)(4).

• Brand Name: CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8640138
• MDR Text Key: 146061731
• Report Number: 3003898360-2019-00562
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• 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: 05/06/2019
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONCHASMART 22MM DUAL LIMB HEATED CIRCUIT KIT; CONCHASMART 22MM DUAL LIMB HEATED CIRCUIT KIT; CONCHASMART 22MM DUAL LIMB HEATED CIRCUIT KIT; CONCHASMART 22MM DUAL LIMB HEATED CIRCUIT KIT