Brand Name | MPS 2 CONSOLE |
Type of Device | CPBP HEAT EXHANGER |
Manufacturer (Section D) |
QUEST MEDICAL, INC. |
one allentown parkway |
allen TX 75002 |
|
Manufacturer (Section G) |
QUEST MEDICAL, INC. |
one allentown parkway |
|
allen TX 75002 |
|
Manufacturer Contact |
tosan
onosode
|
one allentown parkway |
allen, TX 75002
|
9723326338
|
|
MDR Report Key | 9500916 |
MDR Text Key | 190528742 |
Report Number | 1649914-2019-00071 |
Device Sequence Number | 1 |
Product Code |
DTR
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K173716 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/19/2019 |
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 |
No Information
|
Device Model Number | 5201260 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/29/2019 |
Initial Date FDA Received | 12/20/2019 |
Was Device Evaluated by Manufacturer? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|