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

Model Number 0210

Device Problem Connection Problem (2900)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 06/28/2023

Event Type  malfunction  

Manufacturer Narrative

He nebulizer's failure to release aerosol and the tubing popping off would delay treatment for the patient.

Event Description

Tubing does not stay attached.

Manufacturer Narrative

He nebulizer's failure to release aerosol and the tubing popping off would delay treatment for the patient.The reported defect of tubing does not stay attached was not confirmed in the absence of a photo or physical sample.A stock investigation was performed on lot 435573 to determine if the defect was present in stock inventory.The extension tubing was tested dimensionally against drawing 20004, no nonconformance's were found on the stock inventory during investigation.

Event Description

Tubing does not stay attached.

• 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: 17419037
• MDR Text Key: 320060633
• Report Number: 2028807-2023-00022
• Device Sequence Number: 1
• Product Code: CAF
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 09/29/2023
• 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