MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; VIXONE NEBULIZER

Model Number 0210

Device Problem Material Integrity Problem (2978)

Patient Problem Respiratory Insufficiency (4462)

Event Date 12/08/2022

Event Type  malfunction  

Event Description

When the nebulizer started, it did not nebulize medication.

Manufacturer Narrative

When the nebulizer started, it did not nebulize medication, delaying patient treatment.

Manufacturer Narrative

When the nebulizer started, it did not nebulize medication, delaying patient treatment.The defect of failure to nebulize could not be confirmed in the absence of a photo or sample.The risk associated with failure to nebulize was identified as 6-major which is below the threshold for immediate escalation.Airlife will continue to monitor complaints and trending.

Event Description

When the nebulizer started, it did not nebulize medication.

• Brand Name: WESTMED LLC
• Type of Device: VIXONE NEBULIZER
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18051735
• MDR Text Key: 327145641
• Report Number: 2028807-2023-00029
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00709078000409
• UDI-Public: 00709078000409
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0210
• Device Catalogue Number: 0210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other