MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-13 for AXIOM ARTIS ZEE manufactured by Siemens Medical Solutions Usa, Inc.
[116886648]
Patient placed on table in ir (interventional radiology) room 1: siemens artis biplane room. After starting the procedure the table locked and it couldn't be moved. Lost ability to use tableside controls. Manufacturer response for ir angiography suite, axiom artis (per site reporter) : pending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7776261 |
| MDR Report Key | 7776261 |
| Date Received | 2018-08-13 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-07-25 |
| Report Date | 2018-08-08 |
| Date Reported to FDA | 2018-08-08 |
| Date Reported to Mfgr | 2018-08-13 |
| Date Added to Maude | 2018-08-13 |
| 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 |
| Generic Name | STATIONARY ANGIOGRAPHIC X-RAY SYSTEM, DIGITAL |
| Product Code | IZI |
| Date Received | 2018-08-13 |
| Model Number | ZEE |
| Device Availability | Y |
| Device Age | 12 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC |
| Manufacturer Address | 40 LIBERTY BOULEVARD MAILCODE: 65-1A MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-13 |