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 2020-03-30 for O2 BI70002000 manufactured by Medtronic Navigation, Inc (littleton).
[185523526]
The system was serviced and it was discovered that the power tray was getting 110vac in but not getting 48vdc out. The power tray and power enclosure were replaced. The system passed all tests and was performing as intended. The power enclosure and power tray were returned however analysis has not been completed at the time of submitting this report. Other relevant device(s) are: product id: bi71000176r, serial/lot #: (b)(4). Product id: bi71000195, serial/lot #: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185523527]
Medtronic received information regarding an imaging system being used during a spinal procedure. It was reported that the system was able to boot up and got all three green check marks, but the image acquisition system indicated that it was on standalone mode, while the mobile viewing station indicated a firmware mismatch. The system was rebooted three times, but the issue was not resolved. The imaging system was aborted. There was no patient harm and the procedure was not delayed over an hour.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00423 |
| MDR Report Key | 9897531 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-30 |
| 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 | O2 |
| Generic Name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | OWB |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-16 |
| Model Number | BI70002000 |
| Catalog Number | BI70002000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-30 |