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 |
joan
ceasar
|
14401 w. 65th way |
arvada, CO 80004
|
2812287260
|
|
MDR Report Key | 5394837 |
MDR Text Key | 36948541 |
Report Number | 9611109-2016-00002 |
Device Sequence Number | 1 |
Product Code |
DWC
|
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 |
Reporter Occupation |
Physician
|
Remedial Action |
Other |
Type of Report
| Initial,Followup |
Report Date |
01/27/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/27/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | N/A |
Device Lot Number | N/A |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/30/2016 |
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;
|
|
|