MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-31 for O-ARM BI70000028120 manufactured by Medtronic Navigation, Inc (littleton).
[185766182]
The system was serviced in the field. They found error 25 in the logs which is a battery issue. They checked all batteries and took 3 spins with the power unplugged and all batteries held up. They checked the battery and battery indicator connections and all are good. The system passed all tests and was performing as intended. Codes 10, 213 and 67 are applicable. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185766183]
Medtronic received information regarding an imaging system used during a sacroiliac and thoracolumbar procedure. It was reported that they were able to take an ap image, but not a lateral. They rebooted the system and when it came up they took both with no issue. Later on they rolled the system back in for the post-op spin, took ap and lateral with no issue, but were unable to take a 3d spin. They opened and closed the gantry, but did not reboot, they swapped to a c-arm for the post-op check. There is no reported harm to the patient present and there was less then one hour delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00429 |
| MDR Report Key | 9903334 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2014-11-22 |
| 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 | BI70000028120 |
| Catalog Number | BI70000028120 |
| 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 |