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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 Energy Output Problem (1431)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/30/2020
Event Type  Malfunction  
Manufacturer Narrative

The distributor performed a checkout of the equipment and confirmed the reported complaint. The drive gas check valve was replaced to resolve the reported issue. Patient information could not be obtained due to country privacy laws. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Date of device manufacture unknown at time of filing.

 
Event Description

The hospital reported a malfunction in the bellows resulting in the loss of mechanical ventilation. 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 21402 8
CH 214028
Manufacturer Contact
john szalinski
MDR Report Key10459326
MDR Text Key206161667
Report Number9710602-2020-00253
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 08/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/30/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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