MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for OARM O2 IMAGING SYSTEM BI70002000 manufactured by Medtronic Navigation, Inc (littleton).
[184476370]
Concomitant medical products: product id: bi71000168, serial/lot #: unknown. A medtronic representative went to the site to test the equipment. Troubleshooting was performed by removing the covers to access the collimator assembly. The reported issue was confirmed, the collimator was not initializing correctly. It was found that the "stroke error" for the x-leaf was out of specification. The x and y end stops were adjusted. After the adjustment, both x and y collimator leaves passed the stroke check. The collimator to detector alignment was adjusted. The system then performed as intended and passed a system checkout. No hardware parts were replaced. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184476371]
Medtronic received information regarding an imaging system being used outside of a procedure. It was reported that there was an initializing collimator error on the motion bar of the imaging system pendant. The logs showed a problem with the collimator, error 100. 4 (x-leaf failing). There was no patient involved when this issue was discovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004785967-2020-00390 |
| MDR Report Key | 9865445 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-19 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2018-01-29 |
| 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 | 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 | OARM 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 | MEDTRONIC NAVIGATION, INC (LITTLETON) |
| Manufacturer Address | 300 FOSTER ST LITTLETON MA 01460 US 01460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |