MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-11 for AXIOM ICONOS R200 5902775 manufactured by Siemens Healthcare Gmbh.
[145915584]
Table tilt controller and table side controller have been already exchanged at this site. The unit works as specified. Investigation is on-going. A supplemental report will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[145915585]
Siemens became aware of unintended table movements on the axiom iconos r200 unit. The x-ray table tilted from 90 degree to 0 degree position without given command. Siemens is not aware of any patient involvement in this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2019-70845 |
| MDR Report Key | 8504197 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-11 |
| Date of Report | 2019-02-18 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-04-10 |
| Date Added to Maude | 2019-04-11 |
| 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 | 2019-04-11 |
| Model Number | 5902775 |
| 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 | 2019-04-11 |