Brand Name | CAPIOX RX OXYGENATOR |
Type of Device | OXYGENATOR, CARDIOPULMONARY BYPASS |
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 |
terry
callahan
|
reg. no. 2243441 |
2101 cottontail ln. |
somerset, NJ 08873
|
8002837866
|
|
MDR Report Key | 7489891 |
MDR Text Key | 108164470 |
Report Number | 9681834-2018-00072 |
Device Sequence Number | 1 |
Product Code |
DTZ
|
UDI-Device Identifier | 04987350769572 |
UDI-Public | 04987350769572 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K040210 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/07/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/07/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/31/2020 |
Device Catalogue Number | CX*RX25RW |
Device Lot Number | 171117K |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/26/2018 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 04/13/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/17/2017 |
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 |
|
|