MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-15 for AXIOM ICONOS R200 10093962 manufactured by Siemens Healthcare Gmbh.
[145915288]
Investigation of the reported event is on-going. A supplemental report will be submitted if additional information becomes available. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[145915289]
Siemens became aware of unintended system movement of the axiom iconos r200. During a procedure the operator noticed that the table slowly tilted without any control key or lever being touched on the control desk. The movement was performed towards the head position from 0? (table horizontal) to minus degrees. There are no injuries attributed to this event. The reported event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2019-77543 |
| MDR Report Key | 8514017 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-15 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-04-04 |
| Date Mfgr Received | 2019-08-02 |
| Date Added to Maude | 2019-04-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | ANASTASIA SOKOLOVA |
| Manufacturer Street | 40 LIBERTY BLVD, MC 65-1A |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486478 |
| Manufacturer G1 | SIEMENS HEALTHCARE GMBH |
| Manufacturer Street | SIEMENSSTR.1 |
| Manufacturer City | FORCHHEIM, 91301 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXIOM ICONOS R200 |
| Generic Name | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | JAA |
| Date Received | 2019-04-15 |
| Model Number | 10093962 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH |
| Manufacturer Address | SIEMENSSTR.1 FORCHHEIM, 91301 GM 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-15 |