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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 ANESTHESIA GAS MACHINE

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GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 650 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 05/31/2018
Event Type  Malfunction  
Manufacturer Narrative

No report of patient involvement. (b)(4). The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. The frame interface board was replaced to resolve the reported issue.

 
Event Description

The hospital reported the system showed an error message stating malfunction with bag symbol showing. There was no report of patient involvement.

 
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Brand NameCARESTATION 650
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
CH
Manufacturer Contact
joseph seliga
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7644556
MDR Text Key112566081
Report Number9710602-2018-00170
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
PMA/PMN NumberK151570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Type of Report Initial
Report Date 06/27/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/28/2018
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
Event Location No Information
Date Manufacturer Received05/31/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/22/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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