MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-20 for O-ARM 1000 IMAGING SYSTEM BI70000027120 manufactured by Medtronic Navigation, Inc (littleton).
[184317813]
Patient information not provided due to canadian patient privacy regulations. A medtronic representative went to the site to test the equipment. Testing revealed that the system control board and the generator cover was adjusted to restore functionality. The imaging system then passed the system checkout and was found to be fully functional. Other relevant device(s) are: product id: bi-500-01093, serial/lot #: unk. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184317834]
Medtronic received information that, while in a spinal fusion, the imaging functionality displayed a red x. It was reported that the imaging system was powered on and initialization was completed. The imaging system was then plugged into the viewing station of the imaging system, the transport brake button was pressed and the issue then occurred. Hard restarts as well as disconnecting and reconnecting the lemo did not restore functionality. The surgeon opted to complete the procedure without the use of the imaging system. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no reported impact on patient outcome.
Patient Sequence No: 1, Text Type: D, B5
[187766192]
A software analysis was initiated as part of the investigation. Analysis found that the issue was unrelated to the software of the imaging system. The software of the imaging system functioned as designed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004785967-2020-00382 |
| MDR Report Key | 9860037 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-20 |
| 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 | MEDTRONIC NAVIGATION, INC (LITTLETON) |
| Manufacturer Street | 300 FOSTER ST |
| Manufacturer City | LITTLETON MA 01460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | O-ARM 1000 IMAGING SYSTEM |
| Generic Name | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE |
| Product Code | OXO |
| Date Received | 2020-03-20 |
| Model Number | BI70000027120 |
| Catalog Number | BI70000027120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC (LITTLETON) |
| Manufacturer Address | 300 FOSTER ST LITTLETON MA 01460 US 01460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |