MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-12 for OARM 1000 3RD EDITION BI70000028120 manufactured by Medtronic Navigation, Inc (littleton).
[183119601]
Other relevant device(s) are: product id: bi71000644r, serial/lot #: (b)(4). A medtronic representative went to the site to test the equipment. Testing revealed that the mobile view station (mvs) computer took more than 5 minutes to boot. The computer was replaced and the configuration file was updated. The system then passed a system checkout. The computer was returned to medtronic and is under analysis at the time of filing. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183119602]
Medtronic received information regarding an imaging system being used outside of a procedure. It was reported that the system's computer was acting very slow and intermittent. This was discovered during a planned maintenance (pm). There was no patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00355 |
| MDR Report Key | 9823948 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-12 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2015-01-23 |
| Date Added to Maude | 2020-03-12 |
| 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 | OARM 1000 3RD EDITION |
| Generic Name | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE |
| Product Code | OXO |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-03-03 |
| Model Number | BI70000028120 |
| Catalog Number | BI70000028120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-12 |