MAUDE Adverse Event Report: SUNSET HEALTHCARE SOLUTIONS SUNSET MINI MESH NEBULIZER

Model Number NEB400

Device Problem Failure to Eject (4010)

Patient Problem Respiratory Distress (2045)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

End user reports the end user was unable to complete treatment using the sunset mini mesh nebulizer (neb400) as the end user reports the unit would not remain powered on.As a result the end user reported having treatment at an emergency room.The unit was returned for evaluation in its opened outer decorative box.It was plugged into the electrical outlet.The light indicator turned green and a small, short squeak was heard when the power button was pressed.No vibration or other activity was noted from the unit.New batteries were then placed into the unit and the same situation occurred.The unit would not stay powered on, root cause has not been determined.

Event Description

End user reports the mesh nebulizer (neb400) would not remain powered on, only staying powered on for a few moments.As a result of the mesh nebulizer malfunctioning, the end user reports going to the emergency room for a treatment.

• Brand Name: SUNSET MINI MESH NEBULIZER
• Type of Device: MESH NEBULIZER
• Manufacturer (Section D): SUNSET HEALTHCARE SOLUTIONS; 180 n. michigan ave; suite 2000; chicago IL 60601
• Manufacturer (Section G): SUNSET HEALTHCARE SOLUTIONS; 180 n. michigan ave; suite 2000; chicago IL 60601
• Manufacturer Contact: nazree williams ; 180 n. michigan ave; suite 2000; chicago, IL 60601 ; 3125332457
• MDR Report Key: 9319111
• MDR Text Key: 190689782
• Report Number: 3006446479-2019-00008
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K170886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NEB400
• Device Catalogue Number: NEB400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention