MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; VIXONE NEBULIZER, W/SUPER SPIKE MASK, THREADED NUT

Model Number 0313

Device Problem Material Integrity Problem (2978)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/05/2023

Event Type  malfunction  

Event Description

Customers saying the nebulizer isn't aerosolizing. .

Manufacturer Narrative

The nebulizer isn't aerosolizing delayed patient treatment.

Event Description

Customers saying the nebulizer isn't aerosolizing. .

Manufacturer Narrative

The nebulizer isn't aerosolizing delayed patient treatment.The defect of failure to nebulize was unable to be confirmed in the absence of a returned sample.Rma-20013f revision 1 has been reviewed.This type of failure has been included and assessed for risk on lines r19-r24, r27, r28, r33, r40, r58, r59, r62-r64, and r81-r84.The highest severity associated with the line items is 6 - major and with an occurrence of up to 4.Airlife will continue to monitor trending of the complaint and may perform additional actions at that time.

• Brand Name: WESTMED LLC
• Type of Device: VIXONE NEBULIZER, W/SUPER SPIKE MASK, THREADED NUT
• 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: 18068625
• MDR Text Key: 327324036
• Report Number: 2028807-2023-00031
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00709078000607
• UDI-Public: 00709078000607
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0313
• Device Catalogue Number: 0313
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2023
• 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