MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-09 for O-ARM 1000 IMAGING SYSTEM BI70000027100 manufactured by Medtronic Navigation, Inc (littleton).
[182701323]
Patient information was unavailable. Other relevant device(s) are: product id: bi71000579, serial/lot #: unknown, ubd: unknown, udi#: unknown. A medtronic representative went to the site to test the equipment. Testing revealed that the atp board was replaced. The imaging system then passed the system checkout and was found to be fully functional. No parts have been received by the manufacturer for evaluation. (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182701324]
Medtronic received information regarding a navigation system being used for a sacroiliac and thoracolumbar procedure. It was reported that pre-operatively, when starting the image acquisition system (ias), the beep sound rang and the product failed to start. Rebooting was performed several times but the issue persisted. After rebooting for several times, the beep sound disappeared and the product was started normally. Operation was checked and the product was used in the procedure. There was no reported impact to patient outcome and no reported surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00335 |
| MDR Report Key | 9805475 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2012-10-08 |
| Date Added to Maude | 2020-03-09 |
| 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 1000 IMAGING SYSTEM |
| Generic Name | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE |
| Product Code | OXO |
| Date Received | 2020-03-09 |
| Model Number | BI70000027100 |
| Catalog Number | BI70000027100 |
| Device Expiration Date | 2017-08-07 |
| 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 | 2020-03-09 |