Brand Name | CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF |
Type of Device | OXYGENATOR |
Manufacturer (Section D) |
TERUMO CORPORATION, ASHITAKA |
150 maimaigi-cho |
fujinomiya city, shizuoka 418 |
JA 418 |
|
Manufacturer (Section G) |
TERUMO CORPORATION, ASHITAKA |
reg. no. 9681834 |
150 maimaigi-cho |
fujinomiya city, shizuoka 418 |
JA
418
|
|
Manufacturer Contact |
jennifer
suh
|
reg. no. 2243441 |
2101 cottontail ln. |
somerset, NJ 08873
|
8002837866
|
|
MDR Report Key | 5904054 |
MDR Text Key | 53002668 |
Report Number | 9681834-2016-00206 |
Device Sequence Number | 1 |
Product Code |
DTZ
|
UDI-Device Identifier | 04987350701206 |
UDI-Public | 04987350701206 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K071494 |
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 |
08/25/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/25/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 11/30/2018 |
Device Catalogue Number | 1CX*FX15W |
Device Lot Number | 151215 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/06/2016 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 09/06/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/16/2015 |
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 |
|
|