MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-25 for O-ARM BI70002000 manufactured by Sanmina -sci Systems.
[185003243]
A medtronic representative went to the site to test the equipment. Testing revealed that the reported event was unable to be replicated. 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
[185003244]
Medtronic received information regarding an imaging system being used for a sacroiliac and thoracolumbar procedure. It was reported the system was unable to acquire a 3d image. The use of imaging was aborted. There was no reported impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006544299-2020-00102 |
| MDR Report Key | 9879223 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-06-24 |
| Date Added to Maude | 2020-03-25 |
| 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 | 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 | O-ARM |
| Generic Name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | OWB |
| Date Received | 2020-03-25 |
| 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 | 2020-03-25 |