Brand Name | AESTIVA MRI |
Type of Device | ANESTHESIA GAS MACHINE |
Manufacturer (Section D) |
DATEX-OHMEDA, INC. |
3030 ohmeda dr, |
madison, WI |
|
Manufacturer Contact |
joseph
seliga
|
3000 n grandview blvd. |
waukesha, WI
|
|
MDR Report Key | 7496358 |
MDR Text Key | 107691433 |
Report Number | 2112667-2018-00926 |
Device Sequence Number | 1 |
Product Code |
BSZ
|
Combination Product (y/n) | N |
PMA/PMN Number | K993410 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial |
Report Date |
05/08/2018 |
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? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/12/2018 |
Initial Date FDA Received | 05/08/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/05/2012 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|