O-ARM O2 IMAGING SYSTEM Adverse Event — Malfunction (MDR 3004785967-2020-00506)
O-ARM O2 IMAGING SYSTEM Adverse Event — Malfunction (MDR 3004785967-2020-00506) 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: MEDTRONIC NAVIGATION, INC (LITTLETON).
| Device | O-ARM O2 IMAGING SYSTEM |
|---|---|
| Generic name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Manufacturer | MEDTRONIC NAVIGATION, INC (LITTLETON) |
| Report number | 3004785967-2020-00506 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, USER F |
| Narrative | H3, H6) A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS NOTED THAT THE MACHINE TURNED ON AND BOOTED INTO STAND ALONE MODE, INDICATING A MOTION CALIBRATION WAS NEEDED. THE MANUFACTURER REPRESENTATIVE ATTEMPTED TO OPEN THE DOOR AND IT WOULD NOT OPEN. THE MANUFACTURER REPRESENTATIVE CALIBRATED THE MOTION AND WAS THEN UNABLE TO DUPLICATE THE ISSUE OPENING THE DOOR OUTSIDE OF |
| Source | openFDA MAUDE (device adverse events) |
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