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 2020-03-23 for O-ARM O2 IMAGING SYSTEM BI70002000 manufactured by Sanmina -sci Systems.
[185002056]
Other relevant device(s) are: product id: bi-500-01065 o-arm software - o2, (b)(4), serial/lot : n/a. A medtronic representative went to the site to perform a system check out and the system performed as intended. The system passed all tests. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185002057]
Medtronic received information regarding an imaging system being used during a spinal procedure. It was reported that the technician was holding the button on the remote to conduct the spin, while the manufacturer representative was exiting the room. The representative peaked through the window to verify that the navigation system was seeing the reference frame and the imaging system, but it was found that the navigation system was no longer seeing the imaging system in the camera view. The representative immediately walked back into the room and saw that the mobile viewing station (mvs) was still on, but the pendant on the image acquisition system(ias) was not lit up, which means it was off. The representative pushed the power button and the imaging system powered up right away. The imaging system completed the startup, initialization, and then the surgical team proceeded with the scan. A confirmation scan was performed a few hours later with no issues. There was no patient harm and the procedure was delayed by five minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006544299-2020-00095 |
| MDR Report Key | 9864832 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2020-01-12 |
| 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 | 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 O2 IMAGING SYSTEM |
| Generic Name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | OWB |
| Date Received | 2020-03-23 |
| 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 | 2020-03-23 |