Brand Name | HL-20 TWIN PUMP |
Type of Device | FLOWMETER, BLOOD, CARDIOVASCULAR |
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 | 4944781 |
MDR Text Key | 6037215 |
Report Number | 8010762-2014-00878 |
Device Sequence Number | 1 |
Product Code |
DPW
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K984338 |
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 |
07/31/2013 |
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 | 70102.8692 |
Device Catalogue Number | MCP00703277 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 07/31/2013 |
Event Location |
Hospital
|
Date Report to Manufacturer | 07/31/2013 |
Initial Date Manufacturer Received |
07/31/2013
|
Initial Date FDA Received | 07/28/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |