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 2020-03-24 for O-ARM O2 IMAGING SYSTEM BI70002000 manufactured by Sanmina -sci Systems.
[185002915]
A medtronic representative went to the site to test the equipment. It was reported that the issue could not be confirmed or replicated, no components were replaced. The system then passed the system checkout and was found to be fully functional. Troubleshooting: no matter what settings the manufacturer representative and robotics representative tried, they could not get a low enough "rms" when the head was lateral. When the lateral turn appeared to put the patient's head (and markers in the ct box) closer to the support arm and brought the mayfield adaptor on the robotic system into the field of view of the scan. This in turn caused too much noise for good accuracy. Using the mayfield adaptor on different robotic models did not make a difference in noise. It was further reported there was an issue even with the regular imaging system settings when they first started. After recalibrating the imaging system, the issue reportedly resolved. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185002916]
Medtronic received information regarding an imaging system being used for a cranial procedure with laser ablation (brain tumor). During the first image acquisition, the patient's head was tilted. The site used the default ap and lateral shots, which omitted "z's" on the frame and frame bottom that were necessary for auto-registration. A second image acquisition was taken by wagging the gantry and moving the x-ray tube detector to get true ap and lateral images. The image acquisition successfully included al the "z's" and frame bottom. However, the image appeared blurry and would not complete auto-registration. The site decided to use the second image acquisition and manually register using the rods that were screwed into the patient as well as a fifth point on the frame as "fiducials". The issue resulted in less than one hour procedure delay. There was no impact on patient outcome. It was noted the site was using a robotic navigation system and reference frame that were non-medtronic products.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006544299-2020-00097 |
| MDR Report Key | 9871801 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2020-01-15 |
| Date Added to Maude | 2020-03-24 |
| 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 | 2020-03-24 |
| 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 | 2020-03-24 |