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 2019-04-24 for AXIOM ICONOS R200 5902767 manufactured by Siemens Healthcare Gmbh.
[145916008]
Siemens local service technician was dispatched to the site after the occurrence. The control panel was checked by the technician, who could not determine any defect with the panel. The investigation is on-going. Supplemental report will submit if additional information becomes available. Customer's address: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[145916009]
Siemens became aware of unintended movement of the axiom iconos r200 unit. According to the customer, the unit tilted 31 degrees without given command. There was no patient in the room when the incident occurred. This incident was reported in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2016-06073 |
| MDR Report Key | 8545249 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-24 |
| Date of Report | 2016-10-20 |
| Date of Event | 2016-10-19 |
| Date Mfgr Received | 2018-12-13 |
| Date Added to Maude | 2019-04-24 |
| 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 | 2019-04-24 |
| Model Number | 5902767 |
| 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 | 2019-04-24 |