Brand Name | TEC 7 |
Type of Device | VAPORIZER |
Manufacturer (Section D) |
DATEX-OHMEDA, INC |
3030 ohmeda drive |
madison WI 53718 |
|
Manufacturer (Section G) |
DATEX-OHMEDA, INC |
3030 ohmeda drive |
|
madison WI 53718 |
|
Manufacturer Contact |
john
szalinski
|
540 w. northwest highway |
barrington, IL 60010-3076
|
8472774719
|
|
MDR Report Key | 4925184 |
MDR Text Key | 22445440 |
Report Number | 2112667-2015-00066 |
Device Sequence Number | 1 |
Product Code |
CAD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K012924 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Biomedical Engineer
|
Report Date |
06/27/2012 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/20/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/06/2012 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/13/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/07/2010 |
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 |
|
|