MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-19 for VIVID E95 manufactured by Ge Vingmed Ultrasound As.
| Report Number | 9610482-2020-00002 |
| MDR Report Key | 9727507 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-12-09 |
| Date Added to Maude | 2020-02-19 |
| 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 | JOSEPH TAMBLYN |
| Manufacturer Street | 9900 W INNOVATION DR MAIL DROP: RP-B4422 |
| Manufacturer City | WAUWATOSA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIVID E95 |
| Generic Name | SYSTEM, IMAGING, ULTRASOUND |
| Product Code | IYN |
| Date Received | 2020-02-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE VINGMED ULTRASOUND AS |
| Manufacturer Address | STRANDPROMENADEN 45 HORTEN N-3191 NO N-3191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |