Brand Name | CAPIOX FX OXYGENATOR |
Type of Device | OXYGENATOR, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
TERUMO CORPORATION, ASHITAKA |
150 maimaigi-cho |
fujinomiya city, 418 |
JA 418 |
|
Manufacturer (Section G) |
TERUMO CORPORATION, ASHITAKA |
reg. no. 9681834 |
150 maimaigi-cho |
fujinomiya city, 418 |
JA
418
|
|
Manufacturer Contact |
theresa
mussaw
|
reg. no. 2243441 |
265 davidson ave suite 320 |
somerset, nj
|
2837866718
|
|
MDR Report Key | 10137112 |
MDR Text Key | 214801594 |
Report Number | 9681834-2020-00088 |
Device Sequence Number | 1 |
Product Code |
DTZ
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K071494 |
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 |
Report Date |
06/10/2020 |
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 Expiration Date | 02/28/2021 |
Device Catalogue Number | CX-CRX05101A |
Device Lot Number | 190911 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/15/2020 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/12/2020 |
Initial Date FDA Received | 06/10/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/11/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |