MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-19 for SIEMENS ARTIS Q BIPLANE manufactured by Siemens Healthcare Gmbh.
[142507288]
Images were blurred. A 3d spin was performed to better assist in the care of the sub arachnoid hemorrhage patient whose care was being performed in ipp 9. Proper protocol was followed in producing the 3d spin but upon visualization of the data on the syngo workstation it had become clear that the system malfunctioned. The blood vessel was blurred and the imaging unusable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8531184 |
| MDR Report Key | 8531184 |
| Date Received | 2019-04-19 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-03-09 |
| Report Date | 2019-03-12 |
| Date Reported to FDA | 2019-03-12 |
| 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 | SIEMENS ARTIS Q BIPLANE |
| Generic Name | SYSTEM, X-RAY, ANGIOGRAPHIC |
| Product Code | IZI |
| Date Received | 2019-04-19 |
| 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 |