Brand Name | TEC 6 PLUS |
Type of Device | VAPORIZER |
Manufacturer (Section D) |
DATEX-OHMEDA, INC. |
3030 ohmeda dr, |
madison, WI 53718 |
|
MDR Report Key | 11087347 |
MDR Text Key | 224820631 |
Report Number | 2112667-2020-03633 |
Device Sequence Number | 1 |
Product Code |
CAD
|
Combination Product (y/n) | N |
PMA/PMN Number | K000275 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Type of Report
| Initial,Followup |
Report Date |
01/25/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/29/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 01/08/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|