Brand Name | CARESTATION 650 A1 |
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 Contact |
john
szalinski
|
3000 n grandview blvd. |
waukesha, WI
|
|
MDR Report Key | 7876480 |
MDR Text Key | 120258917 |
Report Number | 9710602-2018-00230 |
Device Sequence Number | 1 |
Product Code |
BSZ
|
Combination Product (y/n) | N |
PMA/PMN Number | K151570 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial |
Report Date |
09/14/2018 |
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? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/17/2018 |
Initial Date FDA Received | 09/14/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/16/2017 |
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 |
|
|