Device product
Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to produce medicated aerosol particles for respiratory therapy for both children and adults.
Z-1058-2019
Product summary
- Event
- Event 81725
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150 units
- Official record key
device-enforcement:Z-1058-2019
Official wording
Reason: The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off.
Code information: Lot number 180223
Distribution pattern: International distribution in the country of South Africa.
Derived failure modes
-
Unknown
The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off.