Brand Name | SORIN HEATER-COOLER SYSTEM 3T |
Type of Device | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
SORIN GROUP DEUTSCHLAND |
lindberghstr. 25 |
munich, 80939 |
GM 80939 |
|
Manufacturer (Section G) |
SORIN GROUP DEUTSCHLAND |
lindberghstr. 25 |
|
munich, 80939 |
GM
80939
|
|
Manufacturer Contact |
carrie
wood
|
14401 w. 65th way |
arvada, CO 80004
|
3034676461
|
|
MDR Report Key | 5540239 |
MDR Text Key | 41614418 |
Report Number | 9611109-2016-00224 |
Device Sequence Number | 1 |
Product Code |
DWC
|
Combination Product (y/n) | N |
Reporter Country Code | CO |
PMA/PMN Number | K052601 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Health Professional
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
02/17/2016 |
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 | 16-02-85 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/17/2016 |
Initial Date FDA Received | 03/31/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/12/2004 |
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 |
|
|