Brand Name | STERILE FX25RWC W/ RES |
Type of Device | BLOOD GAS OXYGENATOR |
Manufacturer (Section D) |
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
125 blue ball road |
elkton MD 21921 |
|
Manufacturer (Section G) |
|
Manufacturer Contact |
jamie
quinlan
|
125 blue ball road |
elkton, MD 21921
|
8002837866
|
|
MDR Report Key | 10976372 |
MDR Text Key | 220508273 |
Report Number | 1124841-2020-00278 |
Device Sequence Number | 1 |
Product Code |
DTZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K151791 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
01/21/2021 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 12/09/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | 3CX*FX25RWC |
Device Catalogue Number | N/A |
Device Lot Number | XG10 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/14/2020 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 01/15/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/10/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|