MAUDE Adverse Event Report: TELEFLEX MEDICAL TELEFLEX NEPTUNE HEATER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Catalog Number 870-19KIT

Device Problems Melted (1385); Material Puncture/Hole (1504)

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

Event Date 04/04/2021

Event Type  malfunction  

Event Description

Heated high flow cannula system (teleflex neptune heater and conchasmart breathing system with single limb) was found off the patient laying on the patents bed.The heater was on and the flowmeter was on.An area of the corrugated tubing was observed to be melted with an open hole.The patient was on bipap.No injury to the patent.Treatment start on (b)(6) 2021.Diagnosis for covid-19, severe ards.

• Brand Name: TELEFLEX NEPTUNE HEATER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC 27560
• MDR Report Key: 11705907
• MDR Text Key: 247004270
• Report Number: MW5100920
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 870-19KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 70