MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-26 for AXIOM ARTIS ZEE manufactured by Siemens Ag/siemens Healthcare Gmbh.
[125107901]
At the point of getting ready to coil the patient, the tube on the angiography machine overheated, an alarm sounded and the machine shut down.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8008679 |
| MDR Report Key | 8008679 |
| Date Received | 2018-10-26 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-09-29 |
| Report Date | 2018-10-19 |
| Date Reported to FDA | 2018-10-19 |
| Date Reported to Mfgr | 2018-10-26 |
| Date Added to Maude | 2018-10-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | AXIOM ARTIS ZEE |
| Generic Name | SYSTEM, X-RAY, ANGIOGRAPHIC |
| Product Code | IZI |
| Date Received | 2018-10-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS AG/SIEMENS HEALTHCARE GMBH |
| Manufacturer Address | 40 LIBERTY BOULEVARD MAILCODE: 65-1A MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-26 |