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 2020-03-13 for O-ARM 1000 BI70000027100R manufactured by Medtronic Navigation, Inc (littleton).
[183367893]
Patient information not provided due to (b)(6) patient privacy regulations. Other relevant device(s) are: product id: bi71000486, serial/lot #: unknown. Product id: bi71000488, serial/lot #: unknown. A medtronic representative went to the site to test the equipment. Testing revealed that the control pendant had poor contact and the motor battery charger was outside of specification. The motor battery charger and control pendant were replaced. The system then passed system checkout and was functioning as expected. Device manufacturing date is unavailable. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183367914]
Medtronic received information regarding an imaging system being used for a sacroiliac and thoracolumbar procedure. It was reported that the image acquisition system (ias) unit of the imaging system suddenly rebooted. After rebooting, the imaging system was used after checking the operation. There was no impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00367 |
| MDR Report Key | 9832334 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| Generic Name | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE |
| Product Code | OXO |
| Date Received | 2020-03-13 |
| Model Number | BI70000027100R |
| Catalog Number | BI70000027100R |
| 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 | 2020-03-13 |