MAUDE Adverse Event Report: WESTMED, INC. UNI-HEART¿ LO-FLO CONTINUOUS NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 100850

Device Problem Failure to Deliver (2338)

Patient Problem No Information (3190)

Event Date 02/06/2018

Event Type  malfunction  

Event Description

Three different uniheart lo-flo continuous nebulizer bubbling and not nebulizing all from same lot number 122617u21.

• Brand Name: UNI-HEART¿ LO-FLO CONTINUOUS NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): WESTMED, INC.; 5580 s nogales hwy; tucson AZ 85706
• MDR Report Key: 7925736
• MDR Text Key: 122352610
• Report Number: 7925736
• 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: 09/24/2018,03/12/2018

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: 100850
• Device Catalogue Number: 100850
• Device Lot Number: 122617U21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1