Brand Name | AISYS CS2 |
Type of Device | ANESTHESIA GAS MACHINE |
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 |
stephanie
cass
|
3000 n. grandview boulevard |
waukesha, WI 53188-1696
|
|
MDR Report Key | 5337828 |
MDR Text Key | 34755633 |
Report Number | 2112667-2015-00517 |
Device Sequence Number | 1 |
Product Code |
BSZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K132530 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
12/15/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/31/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 12/15/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/26/2015 |
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 |
|
|