Brand Name | STOCKERT HEATER COOLER SYSTEM 3T |
Type of Device | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
SORIN GROUP USA, INC. |
14401 west 65th way |
arvada CO 80004 |
|
MDR Report Key | 5513263 |
MDR Text Key | 40735194 |
Report Number | 5513263 |
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 |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/09/2016,03/11/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/21/2016 |
Is this an Adverse Event Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | HEATER/COOLER 3T |
Device Catalogue Number | 16-02-85 |
Device Lot Number | N/A |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/09/2016 |
Device Age | 4 YR |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/09/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Treatment | NO |
Patient Outcome(s) |
Life Threatening;
Required Intervention;
Disability;
|
Patient Age | 62 YR |
|
|