MAUDE Adverse Event Report: WESTMED, INC. MINI-HEART®; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 100612

Device Problem Product Quality Problem (1506)

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

Event Date 11/23/2021

Event Type  malfunction  

Event Description

Staff have indicated that the mini-heart nebulizers are faulty and there is no patent inlet for oxygen.Devices have been removed from use.

Event Description

Staff have indicated that the mini-heart nebulizers are faulty and there is no patent inlet for oxygen.Devices have been removed from use.

• Brand Name: MINI-HEART®
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): WESTMED, INC.; 5580 s nogales hwy; tucson AZ 85706
• MDR Report Key: 13577653
• MDR Text Key: 285936777
• Report Number: 13577653
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 100612
• Device Catalogue Number: 100612
• Device Lot Number: 083021U06
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1