Brand Name | SARNS 8000 CARDIOPLEGIA MONITOR |
Type of Device | COMPUTER, BLOOD-PRESSURE-SARNS 8000 CARDIOPLEGIA MONITOR |
Manufacturer (Section D) |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 jackson road |
ann arbor MI 48103 |
|
Manufacturer Contact |
jan
winder
|
6200 jackson road |
ann arbor, MI 48103
|
7346634145
|
|
MDR Report Key | 4949825 |
MDR Text Key | 6255329 |
Report Number | 1828100-2015-00640 |
Device Sequence Number | 1 |
Product Code |
DSK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K960916 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/29/2015 |
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 | 16414 |
Device Catalogue Number | 16414 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/17/2015
|
Initial Date FDA Received | 07/29/2015 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
|
|