Brand Name | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
Type of Device | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
Manufacturer (Section D) |
MAQUET CARDIOPULMONARY AG |
rastatt |
GM |
|
Manufacturer (Section G) |
BERND RAKOW |
maquet cardiopulmonary ag |
kehler strasse 31 |
76437 rastatt |
GM
|
|
Manufacturer Contact |
|
maquet cardiopulmonary ag |
kehler strasse 31 |
76437 rastatt
|
4972229321
|
|
MDR Report Key | 7079109 |
MDR Text Key | 93768317 |
Report Number | 8010762-2017-00377 |
Device Sequence Number | 1 |
Product Code |
DTM
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K141432 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
02/06/2018 |
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 Expiration Date | 07/03/2019 |
Device Model Number | VKMO 1100 |
Device Catalogue Number | 701049279 |
Device Lot Number | 92229009 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/16/2017 |
Initial Date FDA Received | 12/04/2017 |
Supplement Dates Manufacturer Received | 02/06/2018
|
Supplement Dates FDA Received | 02/06/2018
|
Date Device Manufactured | 07/01/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|