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 2020-03-09 for O-ARM 1000 IMAGING SYSTEM BI70000027120R manufactured by Medtronic Navigation, Inc (littleton).
[183156379]
Patient information was unavailable. Name of initial reporter unknown at the time of filing. A medtronic representative went to the site to test the equipment. Testing revealed that the system motion power was 104vdc and held during heavy usage. The system was used the next day with no issue. Hardware parts were replaced. It was noted that the radiologic technologist (rt) staff suspected that the system was unplugged. The imaging system 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
[183156380]
Medtronic received information regarding an imaging system being used for a sacroiliac and thoracolumbar procedure. It was reported that intra-operatively, the site was able to take 2d images but when they went to take a 3d image, they received a power error message. Use of the imaging system and navigation system was aborted. The procedure was completed and there was no reported patient impact. There was a reported delay to the procedure of less than 1 hour due to this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00336 |
| MDR Report Key | 9805640 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-09 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2010-12-06 |
| 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 | BI70000027120R |
| Catalog Number | BI70000027120R |
| Device Availability | N |
| Device Age | DA |
| 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 |