MAUDE Adverse Event Report: WESTMED, INC. VIXONE SMALL VOLUME NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 00709078000409

Device Problems Product Quality Problem (1506); Obstruction of Flow (2423); Detachment of Device or Device Component (2907); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2022

Event Type  malfunction  

Event Description

Eleven (11) small volume nebulizer failures: 8 - medication bubbles but no aersol produced even after reseating the baffle.Three (3) - capillary tube blocked/obstructed and popping off the nebulizer cup, no flow to cup.Unable to see blockage.Fda safety report id # (b)(4).

• Brand Name: VIXONE SMALL VOLUME NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): WESTMED, INC.; tucson AZ 85706
• MDR Report Key: 15562848
• MDR Text Key: 301564179
• Report Number: MW5112489
• Device Sequence Number: 7
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/05/2022
• 11 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 00709078000409
• Device Catalogue Number: 0210
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1