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 06/12/2023

Event Type  malfunction  

Event Description

Tubing becomes disconnected from the ventilator.

Manufacturer Narrative

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

Manufacturer Narrative

The nebulizer's failure to release aerosol and the tubing popping off would delay treatment to the patient.Complaint is not confirmed.Testing of a different lot from inventory was found and units failed so ncmr-03535 was initiated.Reviewed the dhr and no quality issues were identified.Performed a risk analysis with rma-20013f and determined a severity rating of 6/10.Sent a resolution to the customer.

Event Description

Tubing becomes disconnected from the ventilator.

• 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: 17312277
• MDR Text Key: 318900933
• Report Number: 2028807-2023-00020
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• 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: 412159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• 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