Brand Name | TERUMO ADVANCED PERFUSION SYSTEM 1 |
Type of Device | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 |
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 | 5520296 |
MDR Text Key | 41065799 |
Report Number | 1828100-2016-00203 |
Device Sequence Number | 1 |
Product Code |
DTQ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K022947 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/27/2016 |
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 |
Other
|
Device Model Number | 816300 |
Device Catalogue Number | 816300 |
Other Device ID Number | (01)00886799001325 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/22/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/01/2016
|
Initial Date FDA Received | 03/23/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/27/2016
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 08/27/2012 |
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 |
|
|