MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-27 for O-ARM 1000 IMAGING SYSTEM BI70000027120 manufactured by Medtronic Navigation, Inc (littleton).
[185223925]
Other relevant device(s) are: product id: kit svc bi71000514 pcba mvs pwr bd, serial/lot : unk. Product id: kit svc bi71000480 ups pwr sply, serial/lot : unk. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185223926]
Medtronic received information regarding an imaging system being used prior to a procedure. It was reported that the site powered on the system, and them unplugged the mobile viewing station(mvs) from the wall to move it into the or. A minute after being unplugged, the mvs powered off and would not power back on, even after being plugged into a wall. After multiple attempts the site got the mvs to power on and when they went to connect the umbilical cord between the image acquisition system and the mvs, the mvs powered off and became unresponsive. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00418 |
| MDR Report Key | 9888544 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-25 |
| Date Mfgr Received | 2020-03-25 |
| Date Added to Maude | 2020-03-27 |
| 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 | 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 | 2020-03-27 |
| Model Number | BI70000027120 |
| Catalog Number | BI70000027120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-27 |