MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-18 for BREEZY EC 4000 416RADPE manufactured by A&i Industries Ltd..
| Report Number | 2937137-2019-00018 |
| MDR Report Key | 8709777 |
| Date Received | 2019-06-18 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-05-17 |
| Date Mfgr Received | 2019-05-21 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2019-06-18 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GUSTAVO ZAMBRANO |
| Manufacturer Street | 2842 BUSINESS PARK AVE. |
| Manufacturer City | FRESNO CA 93727 |
| Manufacturer Country | US |
| Manufacturer Postal | 93727 |
| Manufacturer Phone | 5592942840 |
| Manufacturer G1 | SUNRISE MEDICAL (US) LLC |
| Manufacturer Street | 2842 BUSINESS PARK AVE. |
| Manufacturer City | FRESNO CA 93727 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93727 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BREEZY EC 4000 |
| Generic Name | MANUAL WHEELCHAIR |
| Product Code | IOR |
| Date Received | 2019-06-18 |
| Model Number | 416RADPE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A&I INDUSTRIES LTD. |
| Manufacturer Address | LIAN DU INDUSTRIES PARK LE LIU TOWN SHUNDE FOSHAN CITY, GUANGDONG CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-06-18 |