MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-24 for ARTIS ZEE FLOOR MN 10094142 * manufactured by Siemens Medical Solutions Usa, Inc..
[15776839]
X-ray imaging system had failed and a video pc board was re-seated on the ias pc. System was stressed multiple times with no issues. Five days later, after a patient was sedated, the system was tested prior to the procedure and the fluoroscopy function was not available. System was rebooted four times with no success. The procedure was cancelled. The replacement pc arrived later that same day and was replaced. System is now fully operational after a week of observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2770156 |
| MDR Report Key | 2770156 |
| Date Received | 2012-09-24 |
| Date of Report | 2012-09-24 |
| Date of Event | 2012-09-17 |
| Report Date | 2012-09-24 |
| Date Reported to FDA | 2012-09-24 |
| Date Added to Maude | 2012-10-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTIS ZEE FLOOR MN |
| Generic Name | X-RAY SYSTEM, CATH/ANGIO, WITH MAGNETIC NAVIGATION |
| Product Code | LMD |
| Date Received | 2012-09-24 |
| Model Number | 10094142 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 3 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 51 VALLEY STREAM PARKWAY MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-24 |