MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-04 for BIPLANE DEVICE A-PLANE OF THE BIPLANE DEVICE WAS THE ONE THAT FAI manufactured by Siemens Healthcare Gmbh.
| Report Number | 8960714 |
| MDR Report Key | 8960714 |
| Date Received | 2019-09-04 |
| Date of Report | 2019-07-15 |
| Date of Event | 2019-07-13 |
| Report Date | 2019-07-15 |
| Date Reported to FDA | 2019-07-15 |
| Date Reported to Mfgr | 2019-09-04 |
| Date Added to Maude | 2019-09-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIPLANE DEVICE |
| Generic Name | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED |
| Product Code | JAA |
| Date Received | 2019-09-04 |
| Model Number | A-PLANE OF THE BIPLANE DEVICE WAS THE ONE THAT FAI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH |
| Manufacturer Address | 40 LIBERTY BOULEVARD MAILCODE: 65-1A MALVERN MA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-04 |