Brand Name | PORTEX GENERAL ANESTHESIA CIRCUITS |
Type of Device | CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
10 bowman dr. |
keene NH 03431 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
10 bowman dr. |
|
keene NH 03431 |
|
Manufacturer Contact |
david
halverson
|
6000 nathan lane north |
aichi pref. |
minneapolis, MN 55442
|
|
MDR Report Key | 11163991 |
MDR Text Key | 226594878 |
Report Number | 3012307300-2021-00345 |
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 |
01/13/2021 |
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 |
No Information
|
Device Catalogue Number | CP12B0/300/000JP |
Device Lot Number | 200903 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/18/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/17/2020
|
Initial Date FDA Received | 01/13/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |