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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 Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 04/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The main board was replaced to resolve the issue.
 
Event Description
The hospital reported that the ventilation monitor fails to switch on.There was no report of patient involvement.
 
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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
CH 
Manufacturer Contact
joseph seliga
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7494379
MDR Text Key107746780
Report Number9710602-2018-00111
Device Sequence Number1
Product Code BSZ
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 05/08/2018
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
Other Device ID NumberSEE H10
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/10/2018
Initial Date FDA Received05/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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