MAUDE Adverse Event Report: WESTMED, INC. HEATED AND HUMIDIFIED ANESTHESIA WICK BREATHING CIRCUIT; HEATED ANESTHESIA BREATHING CIRCUIT

Model Number 9240

Device Problem Charred (1086)

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

Returned unit was examined upon receipt.Examination showed circuit obtained damage due to an electrical fire.The fire was located in the mid-section of the circuit.Upon removing the corrugated tubing that houses the internal components, a small blackened area was noted on the wick.Further examination revealed that the wires showed signs of stress and were broken randomly.

Event Description

Nurse preparing the setup of a heated anesthesia breathing circuit (part number 9240) reported that the controller display showed 70c temporarily.The circuit melted and emitted smoke.

• Brand Name: HEATED AND HUMIDIFIED ANESTHESIA WICK BREATHING CIRCUIT
• Type of Device: HEATED ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): WESTMED, INC.; 5580 s. nogales highway; tucson AZ 85706
• Manufacturer (Section G): WESTMED DE SA DE CV; blvd encino @100; parque industrial tecate; tecate, baja california 21430 ; MX 21430
• Manufacturer Contact: diana upp ; 5580 south nogales highway; tucson, AZ 85706 ; 5202947987
• MDR Report Key: 6498538
• MDR Text Key: 73130132
• Report Number: 2028807-2017-00001
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 00709078001727
• UDI-Public: 00709078001727
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K881451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 9240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1