Brand Name | AVANCE CS2 |
Type of Device | ANESTHESIA GAS MACHINE |
Manufacturer (Section D) |
DATEX-OHMEDA, INC. |
3030 ohmeda dr, |
madison, WI 53718 |
|
MDR Report Key | 7875159 |
MDR Text Key | 120237246 |
Report Number | 2112667-2018-01800 |
Device Sequence Number | 1 |
Product Code |
BSZ
|
Combination Product (y/n) | N |
PMA/PMN Number | K123125 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Type of Report
| Initial,Followup,Followup |
Report Date |
12/19/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/15/2018
|
Initial Date FDA Received | 09/13/2018 |
Supplement Dates Manufacturer Received | 09/14/2018 12/06/2018
|
Supplement Dates FDA Received | 10/12/2018 12/19/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 52 YR |
Patient Weight | 74 |
|
|