Brand Name | CUSTOM TUBING PACK |
Type of Device | CARDIOPULMONARY |
Manufacturer (Section D) |
DATASCOPE CORP. |
fairfield 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
|
9737097265
|
|
MDR Report Key | 4644967 |
MDR Text Key | 5599115 |
Report Number | 2248146-2015-00017 |
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,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/23/2015 |
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 | BO TOP 26300 |
Device Catalogue Number | 701050975 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/23/2015
|
Initial Date FDA Received | 03/24/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |