MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-09 for GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM manufactured by Ge Hangwei Medical Systems Co., Ltd..
| Report Number | 9613445-2019-00007 |
| MDR Report Key | 9172682 |
| Date Received | 2019-10-09 |
| Date of Report | 2019-10-09 |
| Date Mfgr Received | 2019-09-09 |
| Device Manufacturer Date | 2002-01-04 |
| Date Added to Maude | 2019-10-09 |
| 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 | JACQUI BUDDE |
| Manufacturer Street | 3200 N. GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM |
| Generic Name | NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2019-10-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-10-09 |