Brand Name | ROTAFLOW CENTRIFUGAL PUMP SYSTEM |
Type of Device | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
MAQUET CARDIOPULMONARY GMBH |
neue rottenburger strasse 37 |
hechingen |
|
MDR Report Key | 8686731 |
MDR Text Key | 147605270 |
Report Number | 8010762-2019-00167 |
Device Sequence Number | 1 |
Product Code |
DTQ
|
Combination Product (y/n) | N |
PMA/PMN Number | K991864 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,foreign,health profe |
Type of Report
| Initial,Followup |
Report Date |
08/27/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/11/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | ROTAFLOW |
Device Catalogue Number | 701022161 |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 05/23/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|