MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for O-ARM BI70000028120 manufactured by Medtronic Navigation, Inc (littleton).
[184916341]
Patient identifier not available from the site. Patient age not available from the site. Patient weight not available from the site. Patient ethnicity and race not available from the site. Concomitant medical products: product id: bi30000060 rev. 8: (b)(4). A medtronic representative went to the site to test the equipment. Testing revealed items in the logs showing the system acting irregularly. The gantry motion controller was replaced. The imaging system then passed the system checkout and was found to be fully functional. The gantry motion controller was received by the manufacturer, however analysis results were not available at the time of filing. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184916342]
Medtronic received information regarding an imaging system being used for a sacroiliac and thoracolumbar procedure. It was reported the gantry was unable to close. It was noted the gantry was closed but the system showed the gantry was open. The site rebooted the system and the system displayed that it was in standalone mode and that they needed to calibrate motion by pressing "m. " however, pressing "m" did not appear to do anything, as there was no motion in the gantry. A c-arm was used to finish the procedure. This issue occurred intraoperatively during the post operative confirmation image acquisition and caused a less than one hour surgical delay. There was no reported impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00409 |
| MDR Report Key | 9879088 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2014-12-26 |
| Date Added to Maude | 2020-03-25 |
| 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 | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NAVIGATION, INC (LITTLETON) |
| Manufacturer Street | 300 FOSTER ST |
| Manufacturer City | LITTLETON MA 01460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | O-ARM |
| Generic Name | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE |
| Product Code | OXO |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-12 |
| Model Number | BI70000028120 |
| Catalog Number | BI70000028120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC (LITTLETON) |
| Manufacturer Address | 300 FOSTER ST LITTLETON MA 01460 US 01460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |