Brand Name | INNOVA 2121-IQ |
Type of Device | INTERVENTIONAL FLUOROSCOPIC X-RAY |
Manufacturer (Section D) |
GE MEDICAL SYSTEMS SCS |
283 rue de la miniere |
buc, yvelines 7853 0 |
FR 78530 |
|
Manufacturer (Section G) |
GE MEDICAL SYSTEMS SCS |
|
|
buc, yvelines 7853 0 |
FR
78530
|
|
Manufacturer Contact |
paul
corrigan
|
3000 n. grandview blvd |
w450 |
waukesha, WI 53188
|
4142130021
|
|
MDR Report Key | 3819934 |
MDR Text Key | 15877117 |
Report Number | 9611343-2014-00066 |
Device Sequence Number | 1 |
Product Code |
JAA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K060259 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/14/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/14/2014
|
Initial Date FDA Received | 05/14/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/01/2007 |
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 |
Patient Outcome(s) |
Death;
|
Patient Age | 75 YR |
|
|