Brand Name | O-ARM O2 IMAGING SYSTEM |
Type of Device | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
Manufacturer (Section D) |
SANMINA -SCI SYSTEMS |
km 15.5 no. 29, plant 06 |
carr. chapala-guadalajara,jal 45640 |
MX 45640 |
|
Manufacturer (Section G) |
SANMINA -SCI SYSTEMS |
km 15.5 no. 29, plant 06 |
|
carr. chapala-guadalajara,jal 45640 |
MX
45640
|
|
Manufacturer Contact |
glen
belmer
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
6122713209
|
|
MDR Report Key | 13233560 |
MDR Text Key | 284637447 |
Report Number | 3004785967-2022-00019 |
Device Sequence Number | 1 |
Product Code |
OWB
|
UDI-Device Identifier | 00763000132378 |
UDI-Public | 00763000132378 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K200074 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
01/11/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/11/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | BI70002000 |
Device Catalogue Number | BI70002000 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 01/06/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/18/2019 |
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 |
|
|