MAUDE Adverse Event Report: SUNSET HEALTHCARE SOLUTIONS NEB100 COMPRESSOR NEBULIZER

Model Number NEB100

Device Problem Failure to Power Up (1476)

Patient Problem Asthma (1726)

Event Date 06/16/2019

Event Type  Injury  

Manufacturer Narrative

Customer reports the neb100 compressor nebulizer did not power on requiring the end user to seek medical attention for asthma.The device was not returned to the manufacturer and thus additional investigation is not possible.

Event Description

The end user reported the compressor nebulizer (neb100) would not power on right out of the box during an asthma attack.End user reports going to the emergency room for treatment.

• Brand Name: NEB100 COMPRESSOR NEBULIZER
• Type of Device: COMPRESSOR 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: 9541238
• MDR Text Key: 188933548
• Report Number: 3006446479-2019-00009
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00848530087326
• UDI-Public: 00848530087326
• Combination Product (y/n): N
• PMA/PMN Number: K091272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NEB100
• Device Catalogue Number: NEB100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention