Brand Name | HL-20 INTEGRATED PERFUSION SYSTEM |
Type of Device | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
MAQUET CARDIOPULMONARY AG |
kehler strasse 31 |
rastatt, 7643 7 |
GM 76437 |
|
Manufacturer (Section G) |
MAQUET CARDIOPULMONARY AG |
kehler strasse 31 |
|
rastatt, 7643 7 |
GM
76437
|
|
Manufacturer Contact |
tina
evancho
|
45 barbour pond drive |
wayne, NJ 07470
|
9737097265
|
|
MDR Report Key | 4944702 |
MDR Text Key | 6193491 |
Report Number | 8010762-2015-00615 |
Device Sequence Number | 1 |
Product Code |
DTQ
|
Combination Product (y/n) | N |
Reporter Country Code | SZ |
PMA/PMN Number | K943803 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/10/2014,01/30/2014 |
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 | 70102.7652 |
Device Catalogue Number | MCP00703309 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/10/2014 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 01/30/2014 |
Event Location |
Hospital
|
Date Report to Manufacturer | 02/10/2014 |
Initial Date Manufacturer Received |
01/30/2014 |
Initial Date FDA Received | 07/28/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 |