Brand Name | SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) |
Type of Device | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING |
Manufacturer (Section D) |
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
6200 jackson road |
ann arbor MI 48103 |
|
Manufacturer (Section G) |
|
Manufacturer Contact |
douglas
patton
|
6200 jackson road |
ann arbor, MI 48103
|
7346634145
|
|
MDR Report Key | 7763503 |
MDR Text Key | 116542895 |
Report Number | 1828100-2018-00412 |
Device Sequence Number | 1 |
Product Code |
DWC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K883603 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup |
Report Date |
09/26/2018 |
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 | 4415 |
Device Catalogue Number | 4415 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/16/2018 |
Initial Date FDA Received | 08/08/2018 |
Supplement Dates Manufacturer Received | 09/10/2018
|
Supplement Dates FDA Received | 09/26/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
|
|