MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; ANAPOD HUMI-THERM WICK TRANSPORT CIRCUIT, 48", 28V

Model Number A9244, A2003-1

Device Problems Fire (1245); Mechanical Problem (1384)

Patient Problems Burn(s) (1757); Respiratory Distress Syndrome of Newborns (2046)

Event Date 10/19/2022

Event Type  Injury  

Manufacturer Narrative

The anapod humi-therm heated and humidified wick breathing circuit device to the helicopter oxygen and the anapod to the helicopter electric outlet noted a fire in the circuit.The circuit was removed from the patient and removed from the helicopter.The patient had soot in the nares and developed immediate respiratory distress.As it caught fire and burned the nares of the patient and caused immediate respiratory distress to the patient, causing the patient to be intubated.

Event Description

Shortly after connecting the anapod humi-thermheated and humidified wick breathing circuit device to the helicopter oxygen and the anapod to the helicopter electric outlet a fire was noted in the circuit.The circuit was removed from the patient and removed from the helicopter.The patient had soot in the nares and developed immediate respiratory distress.The patient was intubated and was found to have burns in the nares.

• Brand Name: WESTMED LLC
• Type of Device: ANAPOD HUMI-THERM WICK TRANSPORT CIRCUIT, 48", 28V
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales hwy; tucson AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales hwy; tucson AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 15756373
• MDR Text Key: 303279489
• Report Number: 2028807-2022-00021
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A9244, A2003-1
• Device Catalogue Number: A9244, A2003-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other