Brand Name | PORTEX ANESTHESIA CIRCUIT |
Type of Device | CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) PRODUCT CODE: CAI |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC |
6000 nathan lane north |
|
minneapolis MN 55442 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
|
MDR Report Key | 8602513 |
MDR Text Key | 144810457 |
Report Number | 3012307300-2019-02639 |
Device Sequence Number | 1 |
Product Code |
CAI
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
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 |
05/12/2019 |
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 |
Health Professional
|
Device Expiration Date | 05/12/2021 |
Device Catalogue Number | CA13E0/400/000JP |
Device Lot Number | 3732165 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/16/2019 |
Initial Date Manufacturer Received |
04/12/2019
|
Initial Date FDA Received | 05/12/2019 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/07/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |