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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 650 A1 ANESTHESIA GAS MACHINE

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GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 650 A1 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Sticking (1597)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/10/2018
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system but could not reproduce the reported issue. The drive gas check valve was replaced. Patient information could not be obtained due to country privacy laws. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws.
 
Event Description
The hospital reported that the unit could not vent the patient because the bellows was stuck at the top. There was no report of patient injury.
 
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Brand NameCARESTATION 650 A1
Type of DeviceANESTHESIA 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
john szalinski
3000 n grandview blvd.
waukesha, WI 53188
8479711808
MDR Report Key7573360
MDR Text Key110593538
Report Number9710602-2018-00144
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier00840682103947
UDI-Public010084068210394721SM717500086WA11171215
Combination Product (y/n)N
PMA/PMN Number
K151570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 06/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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