Brand Name | AISYS CS2 |
Type of Device | ANESTHESIA GAS MACHINE |
Manufacturer (Section D) |
DATEX-OHMEDA, INC. |
3030 ohmeda dr, |
madison, WI 53718 |
|
MDR Report Key | 10835673 |
MDR Text Key | 216105538 |
Report Number | 2112667-2020-03151 |
Device Sequence Number | 1 |
Product Code |
BSZ
|
Combination Product (y/n) | N |
PMA/PMN Number | K132530 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial,Followup |
Report Date |
03/16/2021 |
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
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/16/2020 |
Initial Date FDA Received | 11/13/2020 |
Supplement Dates Manufacturer Received | 02/17/2021
|
Supplement Dates FDA Received | 03/16/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|