Brand Name | OXYGENATOR |
Type of Device | OXYGENATOR, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
MAQUET CARDIOPULMONARY GMBH |
neue rottenburger strasse 37 |
hechingen |
|
Manufacturer (Section G) |
NURSEL BOELENS |
maquet cardiopulmonary ag |
kehler strasse 31 |
rastatt 76437 |
GM
76437
|
|
Manufacturer Contact |
|
maquet cardiopulmonary ag |
kehler strasse 31 |
rastatt 76437
|
4972229321
|
|
MDR Report Key | 11213807 |
MDR Text Key | 228218849 |
Report Number | 8010762-2021-00021 |
Device Sequence Number | 1 |
Product Code |
DTZ
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K132829 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/09/2021 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 01/22/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | QUADROX-I SMALL ADULT/ADULT |
Device Catalogue Number | 70107.0061 |
Device Lot Number | 92294466 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/29/2021 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 02/24/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/28/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
|
Type of Device Usage |
|