Brand Name | O-ARM 1000 IMAGING SYSTEM |
Type of Device | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE |
Manufacturer (Section D) |
MEDTRONIC NAVIGATION, INC. (LITTLETON) |
300 foster street |
littleton MA 01460 |
|
Manufacturer (Section G) |
MEDTRONIC NAVIGATION, INC. (LITTLETON) |
300 foster street |
|
littleton MA 01460 |
|
Manufacturer Contact |
peter
verhey
|
attn:product quality experienc |
826 coal creek circle |
louisville, CO 80027-9710
|
|
MDR Report Key | 7307510 |
MDR Text Key | 101375174 |
Report Number | 1723170-2018-00931 |
Device Sequence Number | 1 |
Product Code |
OXO
|
Combination Product (y/n) | N |
Reporter Country Code | SG |
PMA/PMN Number | K050996 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
03/01/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Radiologic Technologist
|
Device Model Number | BI-700-00027-120 |
Device Catalogue Number | 9732719 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/30/2018 |
Initial Date FDA Received | 03/01/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/11/2008 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |