MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-06-03 for POWERED CHAIR/TRANSPORT CHAIR UNKNOWN manufactured by Champion Manufacturing Inc..
| Report Number | 1834066-2019-00002 |
| MDR Report Key | 8663879 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-06-03 |
| Date of Report | 2019-06-03 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-05-28 |
| Date Added to Maude | 2019-06-03 |
| 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 | CHRISTINE MILLER |
| Manufacturer Street | 2601 INDUSTRIAL PARKWAY |
| Manufacturer City | ELKHART IN 46516 |
| Manufacturer Country | US |
| Manufacturer Postal | 46516 |
| Manufacturer Phone | 8009985018 |
| Manufacturer G1 | CHAMPION MANUFACTURING INC |
| Manufacturer Street | 2601 INDUSTRIAL PARKWAY |
| Manufacturer City | ELKHART IN 46516 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46516 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERED CHAIR/TRANSPORT CHAIR |
| Generic Name | CHAIR, SURGICAL AC-POWERED |
| Product Code | GBB |
| Date Received | 2019-06-03 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHAMPION MANUFACTURING INC. |
| Manufacturer Address | 2601 INDUSTRIAL PARKWAY ELKHART IN 46516 US 46516 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-06-03 |