MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-20 for O-ARM 1000 BI75000022 manufactured by Medtronic Navigation, Inc (littleton).
[184313667]
Other relevant device(s) are: kit svc bi71000644 mvs comp 3. 2. 1. Device evaluation has not been done at the time of submitting this report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184313668]
No issue was alleged. Medtronic received information regarding an imaging system found during planned maintenance. It was reported that the mobile viewing station (mvs) started beeping and then unexpectedly shut down. There was no patient present.
Patient Sequence No: 1, Text Type: D, B5
[187767062]
Other relevant device(s) are: product id: bi3000090, lot /serial #: azp03420478 / (b)(4). Additional information was added to the event description. The manufacturer representative went to the site to test the imaging system. The reported issue was confirmed and the mobile view station (mvs) computer was replaced. Once replaced the issue was resolved. The computer was returned to the manufacture for evaluation and is under analysis at this time. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187767063]
Additional information was received stating that the mobile view station (mvs) computer was beeping, then it shutdown presumably due to a hardware failure within the computer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00385 |
| MDR Report Key | 9860932 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-03-17 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2016-03-31 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Model Number | BI75000022 |
| Catalog Number | BI75000022 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-20 |