Brand Name | OXYGENATOR, CARDIOPULMONARY BYPASS |
Type of Device | OXYGENATOR, CARDIOPULMONARY BYPASS |
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 | 6148618 |
MDR Text Key | 62188062 |
Report Number | 8010762-2016-00708 |
Device Sequence Number | 1 |
Product Code |
DTZ
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K112360 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/01/2016 |
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 Expiration Date | 06/01/2017 |
Device Model Number | HMO 30000-J |
Device Catalogue Number | 701063733 |
Device Lot Number | 70105983 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/19/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/01/2016 |
Initial Date FDA Received | 12/06/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/01/2015 |
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 |