Brand Name | MINI C-ARM |
Type of Device | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE INTENSIFIER |
Manufacturer (Section D) |
GE OEC MEDICAL SYSTEM, INC. |
salt lake city UT 84116 |
|
MDR Report Key | 7938747 |
MDR Text Key | 123266185 |
Report Number | MW5080387 |
Device Sequence Number | 1 |
Product Code |
JAA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
10/03/2018 |
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 |
Health Professional
|
Device Model Number | MINIVIEW 6800 HP |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/04/2018 |
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 57 YR |
|
|