ARTIS ONE Adverse Event — Malfunction (MDR 3004754211-2020-27207)
ARTIS ONE Adverse Event — Malfunction (MDR 3004754211-2020-27207) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ARTIS ONE; Generic name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM; Manufacturer: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD..
| Device | ARTIS ONE |
|---|---|
| Generic name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Manufacturer | SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. |
| Report number | 3004754211-2020-27207 |
| Event type | Malfunction |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. |
| Source | openFDA MAUDE (device adverse events) |
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