MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. AIRLIFE ISOTHERMAL BREATHING CIRCUIT ADULT INSPIRATORY LINE; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Model Number 4618-504

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2022

Event Type  malfunction  

Event Description

Nurse called about the heated circuit.Alarm was beeping and when she went to troubleshoot she found that the wires that attach to the pig tail had burned through.No physical harm to patient.Fda safety report id# (b)(4).

• Brand Name: AIRLIFE ISOTHERMAL BREATHING CIRCUIT ADULT INSPIRATORY LINE
• Type of Device: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
• Manufacturer (Section D): VYAIRE MEDICAL, INC.
• MDR Report Key: 13692228
• MDR Text Key: 286871125
• Report Number: MW5107937
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4618-504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White