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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 05/06/2018
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. Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed.

 
Event Description

The hospital reported that measured values are different from normal and set up values. There was no report of patient involvement.

 
Manufacturer Narrative

Additional information was received stating that this was a monitoring issue only. Tidal volume delivery was not affected. This is not a reportable malfunction. This event is not reportable.

 
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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, 21402 8
CH 214028
Manufacturer Contact
joseph seliga
3000 n grandview blvd.
waukesha, WI 53188
2625443620
MDR Report Key7665246
MDR Text Key113284027
Report Number9710602-2018-00178
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,Followup
Report Date 07/17/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/06/2018
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 Unkown

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