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

Model Number 0210

Device Problem Material Integrity Problem (2978)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 09/08/2023

Event Type  malfunction  

Event Description

Blue piece of nebulizer falls off when package is opened.Treatment delayed up to 15 minutes.

Manufacturer Narrative

The blue piece of nebulizer falls off when package is opened delayed patient treatment by 15 minutes.

Event Description

Blue piece of nebulizer falls off when package is opened.Treatment delayed up to 15 minutes.

Manufacturer Narrative

The blue piece of nebulizer falls off when package is opened delayed patient treatment by 15 minutes.The defect of blue jet falling out of nebulizer upon opening could not be confirmed.A stock investigation for dimensional and proper attachment of the nebulizer jet was performed and the defect could not be replication.(b)(6) has been reviewed.The reported defect most closely matches to r32 which has a severity of 6 and occurrence of 3.Airlife will continue to perform complaint trending and may perform additional actions at that time.

• 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: 17914134
• MDR Text Key: 325411822
• Report Number: 2028807-2023-00028
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0210
• Device Catalogue Number: 0210
• Device Lot Number: 432784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• 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