MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-25 for O-ARM 1000 IMAGING SYSTEM 3RD EDITION BI75000022 manufactured by Medtronic Navigation, Inc (littleton).
[184863614]
Patient information was unavailable. Other relevant device(s) are: product id: bi71000447, serial/lot #: unknown, ubd: unknown, udi#: unknown. A medtronic representative went to the site to test the equipment. Testing revealed that fuse f10 to the isb failed. The isb, fuses, and x-ray relay were 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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184863615]
Medtronic received information regarding an imaging system being used for a sacroiliac and thoracolumbar procedure. It was reported that post-operatively, when trying to take a 2d image, the system went into standalone mode. The pendant showed that the generator was not initialized. The site brought in a second imaging system to do the post-operative spin. This caused no patient impact and no surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00407 |
| MDR Report Key | 9878280 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-23 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2015-04-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 3RD EDITION |
| Generic Name | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE |
| Product Code | OXO |
| Date Received | 2020-03-25 |
| Model Number | BI75000022 |
| Catalog Number | BI75000022 |
| 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 | 2020-03-25 |