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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 Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 10/21/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The hospital reported a leak causing a loss of manual ventilation. There was no report of patient involvement.

 
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Brand NameCARESTATION 650 A1
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 Key9343352
MDR Text Key188207011
Report Number9710602-2019-00177
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 11/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/19/2019
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 Received10/21/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/28/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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