Brand Name | MAQUET HCU 40 |
Type of Device | CONTROLLER, TEMPERATURE, 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 | 8703505 |
MDR Text Key | 148167445 |
Report Number | 8010762-2019-00180 |
Device Sequence Number | 1 |
Product Code |
DWC
|
Combination Product (y/n) | N |
Reporter Country Code | SZ |
PMA/PMN Number | K130300 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/17/2019 |
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 Model Number | HEATER COOLER UNIT |
Device Catalogue Number | 701044054 |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/23/2019 |
Initial Date FDA Received | 06/17/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/27/2018 |
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 |