Brand Name | CS300 |
Type of Device | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
Manufacturer (Section D) |
DATASCOPE MAHWAH |
1300 macarthur blvd. |
mahwah NJ 07430 |
|
Manufacturer (Section G) |
DATASCOPE MAHWAH |
1300 macarthur blvd. |
|
mahwah NJ 07430 |
|
Manufacturer Contact |
|
1300 macarthur blvd. |
mahwah, NJ 07430
|
|
MDR Report Key | 6965775 |
MDR Text Key | 90743427 |
Report Number | 2249723-2017-00669 |
Device Sequence Number | 1 |
Product Code |
DSP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K063525 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/20/2017 |
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 Catalogue Number | 0998-00-3023-53 |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/04/2017 |
Initial Date FDA Received | 10/20/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/01/2009 |
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 |
|
|