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 |