MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-10-28 for PROTEUS XR/A RADIOGRAPHIC SYSTEM 2259973-3 manufactured by Ge Hangwei Medical Systems Co., Ltd..
| Report Number | 9613445-2019-00009 |
| MDR Report Key | 9244755 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-10-28 |
| Date of Report | 2019-10-28 |
| Date of Event | 2019-08-13 |
| Date Mfgr Received | 2019-08-13 |
| Device Manufacturer Date | 2013-10-27 |
| Date Added to Maude | 2019-10-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEVEN WALCZAK |
| Manufacturer Street | 3000 NORTH GRANDVIEW BOULEVARD |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTEUS XR/A RADIOGRAPHIC SYSTEM |
| Generic Name | SYSTEM, X-RAY, STATIONARY |
| Product Code | KPR |
| Date Received | 2019-10-28 |
| Model Number | 2259973-3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
| Manufacturer Address | WEST AREA OF BUILDING NO.3 NO.1 YONGCHANG NORTH ROAD BEIJING 100176 CH 100176 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-28 |