MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-10 for O1 BI70000028230 manufactured by Medtronic Navigation, Inc (littleton).
[183155393]
Patient information was unavailable from the site. (b)(6). No parts have been received by the manufacturer for evaluation. The manufacture date was not available at the time of reporting. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183155474]
Medtronic received information regarding an imaging system being used in a procedure. It was reported that after turning the system on and while moving to the operating room, the system beeped continuously. After connecting the umbilical cord, the beeping continued and the system failed to boot up completely (green bars visible). The site tried to fix the issue with a re-boot that froze with text "initializing systems, please wait... " visible on the image acquisition system (ias) monitor. The site used a different imaging system that was available. After a few unsuccessful reboots, the system booted up correctly. After running the calibrations, the site repeated boot up process five times and was not able to reproduce error. There was less than an hour delay in the case. No impact on patient outcome. Additional information was received stating that the issue occurred when booting up the system when preparing the operating room (or) for operation. - medtronic received information regarding an imaging system being used in a procedure. It was reported that the system malfunctioned in a similar manner. The system beeped continuously after booting and didn? T boot completely. They re-boot the system several times but the it never got past the? Booting phase.? The system was left unpowered for 10 to 15 min, after which the system turned on normally and worked well during the procedure. The issue didn? T cause delay, but slowed down the preparations and caused concerns. There was no impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00348 |
| MDR Report Key | 9812711 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-10 |
| Model Number | BI70000028230 |
| Catalog Number | BI70000028230 |
| 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 | 2020-03-10 |