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

Model Number 0209

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2019

Event Type  malfunction  

Event Description

Respiratory therapists reported equipment failure.4-5 times within the last week in multiple locations.Leaking nebulizer tubing.Rts did not have any of the defective tubing and had not entered any safetynets.Advised to do so going forward in order to track.Tubing leaks at the end where it connects to the wall oxygen.It is used to administer nebulizer treatments (medication).Rts resolved issues by changing tubing.Manufacturer response for nubilizer, (brand not provided) (per site reporter).

• Brand Name: VIXONE
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): WESTMED, INC.; 5580 s nogales hwy; tucson AZ 85706
• MDR Report Key: 9081992
• MDR Text Key: 159008811
• Report Number: 9081992
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2019,05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0209
• Device Lot Number: 072418N01
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1