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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 620 ANESTHESIA GAS MACHINE

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GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) CARESTATION 620 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 05/30/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A ge healthcare service representative performed a checkout of the system and confirmed the reported issue. Using krytox grease, the bag/vent switch was lubricated as described on technical repair manual, and the equipment returned to use.
 
Event Description
The hospital reported that the bag to vent switch was not operating properly. There was no report of patient involvement.
 
Manufacturer Narrative
Additional information was received stating that both manual and mechanical ventilation were still working and available. This was not a reportable malfunction. Additional information was received stating that both manual and mechanical ventilation were still working and available. This was not a reportable malfunction.
 
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Brand NameCARESTATION 620
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
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7644486
MDR Text Key112565618
Report Number9710602-2018-00169
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,Followup
Report Date 07/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberSEE H10
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/11/2018
Was Device Evaluated by Manufacturer? Yes
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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