Brand Name | CARESTATION 650 |
Type of Device | ANESTHESIA GAS MACHINE |
Manufacturer (Section D) |
GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) |
no. 19 changjiang road |
national hi-tech dev. zone |
wuxi 21402 8 |
CH 214028 |
|
Manufacturer (Section G) |
GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) |
no. 19 changjiang road |
national hi-tech dev. zone |
wuxi 21402 8 |
CH
214028
|
|
Manufacturer Contact |
anthony
amenson
|
3030 ohmeda drive |
madison, WI 53718
|
|
MDR Report Key | 18291015 |
MDR Text Key | 330045691 |
Report Number | 9710602-2023-01414 |
Device Sequence Number | 1 |
Product Code |
BSZ
|
UDI-Device Identifier | 00840682103947 |
UDI-Public | (01)00840682103947(11)220211 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K151570 |
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 |
07/11/2024 |
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
|
Device Model Number | A1 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/13/2023 |
Initial Date FDA Received | 12/08/2023 |
Supplement Dates Manufacturer Received | 05/29/2024
|
Supplement Dates FDA Received | 07/11/2024
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/11/2022 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |
|
|