Brand Name | PORTEX |
Type of Device | CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) |
MDR Report Key | 11183777 |
MDR Text Key | 227548529 |
Report Number | 3012307300-2021-00543 |
Device Sequence Number | 1 |
Product Code |
CAI
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Type of Report
| Initial,Followup |
Report Date |
03/23/2021 |
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 Expiration Date | 09/03/2023 |
Device Lot Number | 4041481 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/30/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/03/2020 |
Initial Date FDA Received | 01/18/2021 |
Supplement Dates Manufacturer Received | 02/23/2021
|
Supplement Dates FDA Received | 03/23/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|