Brand Name | TEC 850 |
Type of Device | VAPORIZER |
Manufacturer (Section D) |
DATEX-OHMEDA, INC. |
3030 ohmeda dr, |
madison, WI 53718 |
|
Manufacturer (Section G) |
DATEX-OHMEDA, INC. |
3030 ohmeda dr, |
|
madison, WI 53718 |
|
Manufacturer Contact |
anthony
amenson
|
3030 ohmeda drive |
madison, WI 53718
|
|
MDR Report Key | 18586029 |
MDR Text Key | 333777287 |
Report Number | 2112667-2024-00526 |
Device Sequence Number | 1 |
Product Code |
CAD
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K172702 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup |
Report Date |
03/18/2024 |
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
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/28/2023 |
Initial Date FDA Received | 01/26/2024 |
Supplement Dates Manufacturer Received | 03/15/2024
|
Supplement Dates FDA Received | 03/18/2024
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/08/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |
|
|