Brand Name | ULTIMA ACTIVATOR II REUSABLE DRIVE MECH. |
Type of Device | CLAMPLESS BEATING HEART |
Manufacturer (Section D) |
MAQUET CARDIOVASCULAR, LLC |
wayne NJ |
|
Manufacturer (Section G) |
MAQUET CARDIOVASCULAR, LLC |
45 barbour pond drive |
|
wayne NJ 07470 |
|
Manufacturer Contact |
tina
evancho
|
45 barbour pond drive |
wayne, NJ 07470
|
9737097690
|
|
MDR Report Key | 3949444 |
MDR Text Key | 4602009 |
Report Number | 2242352-2014-00495 |
Device Sequence Number | 1 |
Product Code |
DWS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/07/2014 |
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 | UA-5001 |
Device Lot Number | 130422 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 04/18/2014 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/07/2014
|
Initial Date FDA Received | 05/02/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |