MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for O-ARM 9732719R manufactured by Medtronic Navigation, Inc (littleton).
[186021434]
Other relevant device(s) are: product id: bi31000171, (b)(4). Product id: bi30000145, (b)(4). A medtronic representative went to the site to test the equipment. The manufacturer representative replaced standalone board with accompanying system control board. The imaging system then passed the system checkout and was found to be fully functional. The standalone board and the system control board have been 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
[186021435]
Medtronic received information regarding an imaging system that was used during a sacroiliac and thoracolumbar procedure. It was reported that the site acquired 2d images, but then went to take a 3d and it would not expose. They rebooted the system, but that did not resolve the issue. The site decided to switch to another imaging system to complete the case. The site later turned the system on the system the next day and was able to take a spin, however, when the manufacturer representative was on site to troubleshoot, she turned the system on but the image acquisition system (ias) was getting stuck in initializing please wait. The x-ray was also not booting up. Another re-boot did not resolve the issue. There was a reported delay of less than one hour. There is no known impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00431 |
| MDR Report Key | 9907225 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2010-09-27 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| Model Number | 9732719R |
| Catalog Number | 9732719R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-31 |