Brand Name | HEART LUNG MACHINE |
Type of Device | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
MAQUET CARDIOPULMONARY GMBH |
neue rottenburger strasse 37 |
hechingen |
|
MDR Report Key | 10934498 |
MDR Text Key | 219157137 |
Report Number | 8010762-2020-00417 |
Device Sequence Number | 1 |
Product Code |
DTQ
|
Combination Product (y/n) | N |
PMA/PMN Number | K133598 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Remedial Action |
Replace |
Type of Report
| Initial,Followup |
Report Date |
12/21/2020 |
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 | CARDIOHELP |
Device Catalogue Number | 70104.8012 |
Initial Date Manufacturer Received |
11/30/2020
|
Initial Date FDA Received | 12/02/2020 |
Supplement Dates Manufacturer Received | 12/01/2020
|
Supplement Dates FDA Received | 12/21/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|