MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-02 for NEB100 COMPRESSOR NEBULIZER manufactured by Sunset Healthcare Solutions.
[188933548]
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.
Patient Sequence No: 1, Text Type: N, H10
[188933549]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006446479-2019-00009 |
| MDR Report Key | 9541238 |
| Report Source | CONSUMER |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-06-16 |
| Date Mfgr Received | 2019-06-19 |
| Date Added to Maude | 2020-01-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NAZREE WILLIAMS |
| Manufacturer Street | 180 N. MICHIGAN AVE SUITE 2000 |
| Manufacturer City | CHICAGO IL 60601 |
| Manufacturer Country | US |
| Manufacturer Postal | 60601 |
| Manufacturer Phone | 3125332457 |
| Manufacturer G1 | SUNSET HEALTHCARE SOLUTIONS |
| Manufacturer Street | 180 N. MICHIGAN AVE SUITE 2000 |
| Manufacturer City | CHICAGO IL 60601 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEB100 COMPRESSOR NEBULIZER |
| Generic Name | COMPRESSOR NEBULIZER |
| Product Code | CAF |
| Date Received | 2020-01-02 |
| Model Number | NEB100 |
| Catalog Number | NEB100 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNSET HEALTHCARE SOLUTIONS |
| Manufacturer Address | 180 N. MICHIGAN AVE SUITE 2000 CHICAGO IL 60601 US 60601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-02 |