O-ARM O2 IMAGING SYSTEM Adverse Event — Malfunction (MDR 3006544299-2020-00146)
O-ARM O2 IMAGING SYSTEM Adverse Event — Malfunction (MDR 3006544299-2020-00146) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: O-ARM O2 IMAGING SYSTEM; Generic name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM; Manufacturer: SANMINA -SCI SYSTEMS.
| Device | O-ARM O2 IMAGING SYSTEM |
|---|---|
| Generic name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Manufacturer | SANMINA -SCI SYSTEMS |
| Report number | 3006544299-2020-00146 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT THE ISSUE COULD NOT BE CONFIRMED OR REPLICATED, NO COMPONENTS WERE REPLACED. IT WAS DETERMINED THE ISSUE RESOLVED WITH A SYSTEM REBOOT. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
| Source | openFDA MAUDE (device adverse events) |
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