Brand Name | BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0 |
Type of Device | TUBING, PUMP, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
MAQUET CARDIOPULMONARY GMBH |
neue rottenburger strasse 37 |
hechingen |
|
MDR Report Key | 8645180 |
MDR Text Key | 146229328 |
Report Number | 8010762-2019-00138 |
Device Sequence Number | 1 |
Product Code |
DWE
|
Combination Product (y/n) | N |
PMA/PMN Number | K080592 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,health professional |
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 | 05/28/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 01/14/2021 |
Device Catalogue Number | 701052794 |
Device Lot Number | 70128329 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/21/2019 |
Date Manufacturer Received | 08/26/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|