MAUDE Adverse Event Report: TELEFLEX MEDICAL TELEFLEX HUDSON RCI CONCHASMART NONINVASIVE BREATHING CIRCUIT; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number 425-00

Device Problems Melted (1385); Material Split, Cut or Torn (4008)

Patient Problem Erythema (1840)

Event Date 08/15/2022

Event Type  malfunction  

Event Description

Tubing from heated circuit for patient's trilogy was underneath patient's lue and upon assessing, primary rn discovered that his arm was red from the melted tubing and exposed wires on the circuit.Fda safety report id #(b)(4).

• Brand Name: TELEFLEX HUDSON RCI CONCHASMART NONINVASIVE BREATHING CIRCUIT
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC 27560
• MDR Report Key: 15265981
• MDR Text Key: 298457645
• Report Number: MW5111628
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 425-00
• Device Lot Number: 74F2000836
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Race: White