Brand Name | STOCKERT S5 SYSTEM |
Type of Device | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
SORIN GROUP DEUTSCHLAND |
lindberghstr. 25 |
munich D 80 939 |
GM D 80939 |
|
Manufacturer (Section G) |
SORIN GROUP DEUTSCHLAND |
lindberghstr. 25 |
|
munich D 80 939 |
GM
D 80939
|
|
Manufacturer Contact |
cheri
voorhees, mgr.
|
14401 west 65th way |
arvada, CO 80004
|
3034676527
|
|
MDR Report Key | 3592692 |
MDR Text Key | 4164440 |
Report Number | 1718850-2013-00320 |
Device Sequence Number | 1 |
Product Code |
DTQ
|
Combination Product (y/n) | N |
Reporter Country Code | SA |
PMA/PMN Number | K080832 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Unknown
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
12/15/2013 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 48-50-00 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/15/2013
|
Initial Date FDA Received | 01/10/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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) |
Other;
|
Patient Age | 6 YR |
|
|