Brand Name | ENTRAK 2500 |
Type of Device | RADIOLAOGICAL IMAGE PROCESSING |
Manufacturer (Section D) |
GE OEC MEDICAL SYSTEMS |
384 wright brothers dr. |
salt lake city UT 84116 |
|
Manufacturer Contact |
|
384 wright brothers dr. |
salt lake city, UT 84116
|
8015364952
|
|
MDR Report Key | 4652305 |
MDR Text Key | 5754569 |
Report Number | 1720753-2015-01352 |
Device Sequence Number | 1 |
Product Code |
LLZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/31/2015 |
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 | ENTRAK 2500 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/11/2015 |
Initial Date FDA Received | 03/31/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
|
|