MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for BASE SYS BI70002000 O-ARM SYS O2 manufactured by Sanmina -sci Systems.
[186732084]
Other relevant device(s) are: product id: bi71000522. A manufacturer representative went to the site to test the equipment. It was reported that the mobile viewing station (mvs) will not power on. It was found that the din rail fuses, f1, f2 failed. Fuses were replaced. The imaging system then passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186732085]
Medtronic received information regarding an imaging system being used for a procedure. It was reported that during a case, the imaging system mobile view station (mvs) was not powering on. The system was plugged in overnight, but when going to move the system, the green power line was not illuminated nor did it illuminate when re-plugging the system. They proceeded with the case by using a c-arm. There was no reported impact to patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006544299-2020-00109 |
| MDR Report Key | 9903338 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-01-25 |
| Date Added to Maude | 2020-03-31 |
| 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 | SANMINA -SCI SYSTEMS |
| Manufacturer Street | KM 15.5 NO. 29, PLANT 06 |
| Manufacturer City | CARR. CHAPALA-GUADALAJARA,JAL 45640 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 45640 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BASE SYS BI70002000 O-ARM SYS O2 |
| Generic Name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | OWB |
| Date Received | 2020-03-31 |
| Model Number | BI70002000 |
| Catalog Number | BI70002000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SANMINA -SCI SYSTEMS |
| Manufacturer Address | KM 15.5 NO. 29, PLANT 06 CARR. CHAPALA-GUADALAJARA,JAL 45640 MX 45640 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |