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 2020-03-30 for OARM ASSY BI70000027 SYSTEM PRODUCT manufactured by Medtronic Navigation, Inc (littleton).
[185508313]
No patient involved. No devices were returned to the manufacturer for analysis. Device manufacturing date is unavailable. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185508454]
Medtronic received information regarding an imaging system used outside of procedure. It was reported that the imaging system will not boot. When they turn it on, it says "booting, please wait" and will not progress further than that. If they reboot the system several times, it will sometimes fully boot. No patient present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00422 |
| MDR Report Key | 9897307 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 ASSY BI70000027 SYSTEM PRODUCT |
| Generic Name | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE |
| Product Code | OXO |
| Date Received | 2020-03-30 |
| Model Number | BI70000027 |
| Catalog Number | BI70000027 |
| 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 | 2020-03-30 |