Brand Name | 4 TO 1 PLEGIOX SET |
Type of Device | CARDIOPULMONARY DEVICE |
Manufacturer (Section D) |
DATASCOPE CORP., |
fairfield NJ |
|
Manufacturer Contact |
jason
sousa
|
15 law dr. |
fairfield, NJ 07004
|
9737097256
|
|
MDR Report Key | 3941724 |
MDR Text Key | 18867404 |
Report Number | 2248146-2014-00017 |
Device Sequence Number | 1 |
Product Code |
DWF
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K090533 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
02/04/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/05/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/31/2014 |
Device Model Number | BO-T 8060 |
Device Catalogue Number | 701055828 |
Device Lot Number | 14667-02 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/04/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/01/2012 |
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 |
|
|