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

Model Number NEPTUNE CONCHA HEATED HUMIDIFIER

Device Problems Display or Visual Feedback Problem (1184); Moisture or Humidity Problem (2986)

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

Event Date 03/02/2020

Event Type  malfunction  

Event Description

Ventilator circuit collecting large amount of condensation despite heater wire circuit and q 4 dumping and double wall expiratory filter.Water got into the vent and caused several alarms.Pt continued to be ventilated but vent had to be changed out.This is a hudson teleflex neptune heater, with concha column and heated wire circuits.We have made every modification recommended by mfr and we still continue to have this issue on a widespread basis, vendor is aware.Fda safety report id# (b)(4).

• Brand Name: TELEFLEX NEPTUNE HEATER WITH CONCHA COLUM
• Type of Device: HUMIDIFIER, RESPIRATORY GAS (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC 27560
• MDR Report Key: 9805149
• MDR Text Key: 182894587
• Report Number: MW5093605
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 03/05/2020

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: Health Professional
• Device Model Number: NEPTUNE CONCHA HEATED HUMIDIFIER
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2020
• 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 Outcome(s): Other
• Patient Age: 24 YR