MAUDE Adverse Event Report: TELEFLEX MEDICAL CONCHATHERM NEPTUNE; CONCHA COLUMN

Model Number 425-00

Device Problem Overheating of Device (1437)

Patient Problem Discomfort (2330)

Event Date 01/18/2017

Event Type  malfunction  

Event Description

Excessive heating of the high flow nasal cannula caused crying of the infant.Therefore, the nasal tubing was removed.

• Brand Name: CONCHATHERM NEPTUNE
• Type of Device: CONCHA COLUMN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC 27560
• MDR Report Key: 6300073
• MDR Text Key: 66611313
• Report Number: MW5067634
• Device Sequence Number: 1
• Product Code: BTT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• 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
• Treatment: COMFORT FLO HUMIDIFICATION SYSTEM REF (B)(4).
• Patient Outcome(s): Other
• Patient Weight: 3