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

Model Number 425-00

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Temperature Problem (3022)

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

Event Date 08/12/2021

Event Type  Injury  

Event Description

Tubing used on a humidifier for bubble cpap therapy was interchanged at the expiratory and inspiratory connections.The design of the humidifier does not prevent this.This results in the temperature inside the tubing to measure inaccurately and have potentially higher than appropriate water temperatures.Fda safety report id# (b)(4).

• Brand Name: CONCHATHERM NEPTUNE HEATER HUMID
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX MEDICAL; wayne PA 19087 1603
• MDR Report Key: 12365089
• MDR Text Key: 268221877
• Report Number: MW5103470
• Device Sequence Number: 1
• Product Code: BTT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/20/2021

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: 425-00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2021
• 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): Required Intervention
• Patient Age: 33 DA
• Patient Weight: 2