Brand Name | CARDIOQUIP MODULAR COOLER HEATER |
Type of Device | CARDIOPULMONARY BYPASS DEVICE |
Manufacturer (Section D) |
CARDIOQUIP, LLC |
8422 calibration ct. |
college station TX 77845 |
|
Manufacturer (Section G) |
CARDIOQUIP, LLC |
8422 calibration ct. |
|
college station TX 77845 |
|
Manufacturer Contact |
charley
ford
|
8422 calibration ct. |
college station, TX 77845
|
9796910202
|
|
MDR Report Key | 15839015 |
MDR Text Key | 305539422 |
Report Number | 3007899424-2022-00160 |
Device Sequence Number | 1 |
Product Code |
DWC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K102147 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Non-Healthcare Professional
|
Remedial Action |
Inspection |
Type of Report
| Initial |
Report Date |
11/21/2022 |
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 | MCH-1000(I) |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/21/2022 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 11/21/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/01/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |