MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-23 for O1 BI70000028120 manufactured by Medtronic Navigation, Inc (littleton).
[184472954]
No patient information provided as no patient was involved in this concern. Other relevant device(s) are: product id: bi30000341, serial/lot #: none. The manufacturer representative went to the site to test the imaging system. The reported issue was confirmed and they replaced the second pendant dongle and stand off post due to dongle screw being broken off inside the post. The issue was resolved and the system was tested. The system is functioning properly. The pendant was returned to the manufacture for evaluation. After functional testing, performance testing and visual/physical examination the reported issue was confirmed. Visual inspection noted a connection face plate was damaged preventing thumbscrew threaded end from secure connection. Continuity testing was good. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184472955]
Medtronic received information regarding an imaging system. It was reported outside of a procedure that they were unable to clear e-stop. Technical services recommended that the site check the dongle to make sure it is properly seated. No patient was present at the time of the event. Additional information was received stating that the site did not try to drive the system. The system was able to be manually pushed, but the site did not have to move the system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00391 |
| MDR Report Key | 9865495 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2015-02-20 |
| Date Added to Maude | 2020-03-23 |
| 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 | O1 |
| Generic Name | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE |
| Product Code | OXO |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-16 |
| Model Number | BI70000028120 |
| Catalog Number | BI70000028120 |
| 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 | 2020-03-23 |