MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-14 for ARTIS ZEE FLOOR 10094135 manufactured by Siemens Medical Solutions Usa Inc..
[111431744]
Procedure: right and left heart cath. And possible coronary intervention. Imaging from siemens artis x-ray inadequate. Patient unable to tolerate additional contrast media; transferred to another facility for continued imaging and possible coronary intervention. Approximate age of device: new on (b)(6) 2009; system is 9 years old.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077885 |
| MDR Report Key | 7605317 |
| Date Received | 2018-06-14 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-06-11 |
| Date Added to Maude | 2018-06-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARTIS ZEE FLOOR |
| Generic Name | SYSTEM, X-RAY ANGIOGRAPHIC |
| Product Code | IZI |
| Date Received | 2018-06-14 |
| Model Number | 10094135 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-14 |