MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-26 for O2 BI70002000 manufactured by Sanmina -sci Systems.
[186731982]
Other relevant device(s) are: product id: bi71000159, serial/lot #: none ; product id: bi71000531, serial/lot #: none. The manufacturer representative went to the site to test the imaging system. The reported issue was confirmed and they found that the inner gantry cover was broken at the front lip and the gantry fans were loud and creating a vibration due to a broken fan blade. They replaced the cover and the gantry fans and the vibration was resolved. System tested and was functioning properly. The gantry cover was discarded at the site. The fans returned to the manufacture for evaluation and are under analysis at the time. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186731983]
Medtronic received information regarding an imaging system being used in a cervical spine procedure. It was reported that while attempting to take a spin the system made a loud clunking noise and would not allow them to take the spin. Both navigation and imaging were aborted causing less than an hour delay in the case. No impact on patient outcome. Additional information was received stating the site was able to take two 2d images, but no 3d images. Troubleshooting was not performed. When the system stopped working correctly the site removed it from the case. However, the procedure was completed, but without the imaging system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006544299-2020-00105 |
| MDR Report Key | 9884052 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-19 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2019-10-10 |
| Date Added to Maude | 2020-03-26 |
| 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 | O2 |
| Generic Name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | OWB |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-25 |
| Model Number | BI70002000 |
| Catalog Number | BI70002000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-26 |