Brand Name | AESTIVA 7100 |
Type of Device | ANESTHESIA GAS MACHINE |
Manufacturer (Section D) |
GE HEALTHCARE |
3030 ohmeda dr. |
madison WI 53718 |
|
Manufacturer (Section G) |
GE HEALTHCARE |
3030 ohmeda dr. |
|
madison WI 53718 |
|
Manufacturer Contact |
anthony
amenson
|
3030 ohmeda dr. |
madison, WI 53718
|
6086223124
|
|
MDR Report Key | 15831700 |
MDR Text Key | 306993138 |
Report Number | 2112667-2022-04846 |
Device Sequence Number | 1 |
Product Code |
BSZ
|
Combination Product (y/n) | N |
Reporter Country Code | BG |
PMA/PMN Number | K172045 |
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 |
12/16/2022 |
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 |
10/23/2022
|
Initial Date FDA Received | 11/20/2022 |
Supplement Dates Manufacturer Received | 11/19/2022
|
Supplement Dates FDA Received | 12/16/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/15/2005 |
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 |
|
|