Brand Name | CDI BLOOD PARAMETER MONITORING SYSTEM 500 |
Type of Device | MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500 |
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 | 5771866 |
MDR Text Key | 48860382 |
Report Number | 1828100-2016-00486 |
Device Sequence Number | 1 |
Product Code |
DRY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123039 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/03/2016 |
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 |
Health Professional
|
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/13/2016 |
Initial Date FDA Received | 07/06/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 08/03/2016
|
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 |
|
|