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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
Model Number 1012-9650-000
Device Problems Inappropriate or Unexpected Reset (2959); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Death (1802)
Event Type  malfunction  
Manufacturer Narrative
For the reported event, a ge healthcare service representative performed a checkout of the system and confirmed the reported events. To resolve the reported issue, the central processing unit was replaced.
 
Event Description
This report summarizes 1 malfunction event. A review of the event indicated that model 1012-9650-000 anesthesia gas machine experienced a system reset error resulting in the loss of mechanical ventilation. This report was received from a single source. The reported event did involve a patient.
 
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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 Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key8804168
MDR Text Key151498135
Report Number9710602-2019-00023
Device Sequence Number1
Product Code BSZ
UDI-Device Identifier00840682103947
UDI-Public010084068210394721
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number1012-9650-000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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