MAUDE Adverse Event Report: SUNSET HEALTHCARE SOLUTIONS NEB100 COMPRESSOR NEBULIZER

Model Number	NEB100
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Asthma (1726)
Date of Event	06/16/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: COMPRESSOR NEBULIZER
• Manufacturer (Section D): SUNSET HEALTHCARE SOLUTIONS; 180 n. michigan ave; suite 2000; chicago IL 60601
• MDR Report Key: 9541238
• Report Number: 3006446479-2019-00009
• Device Sequence Number: 11423471
• Product Code: CAF
• UDI-Device Identifier: 00848530087326
• UDI-Public: 00848530087326
• Combination Product (Y/N): N
• PMA/510(K) Number: K091272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

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