MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-19 for ARTIS Q BIPLANE VD11C manufactured by Siemens Healthcare Gmbh.
[142507497]
Diagnostic patient in ipp 8. While using a siemens artis q fluoroscopy machine to acquire the diagnostic images, the attending in the room remarked that he could not visualize the wire adequately enough. Multiple attempts at adjusting contrast of imaging failed to make the wire readily visible without effort. Requiring unnecessary radiation dosage. The attending felt this posed a patient risk and asked us to file a report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8531178 |
| MDR Report Key | 8531178 |
| Date Received | 2019-04-19 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-02-15 |
| Report Date | 2019-03-11 |
| Date Reported to FDA | 2019-03-11 |
| Date Reported to Mfgr | 2019-04-19 |
| Date Added to Maude | 2019-04-19 |
| 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 | ARTIS Q BIPLANE |
| Generic Name | SYSTEM, X-RAY, ANGIOGRAPHIC |
| Product Code | IZI |
| Date Received | 2019-04-19 |
| Model Number | VD11C |
| 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 | 2 EDGEWATER DRIVE NORWOOD MA 02062 US 02062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-19 |