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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 Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
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. The distributor performed a checkout of the equipment and confirmed the reported complaint. The flow transducer was replaced to resolve the issue.
 
Event Description
The hospital reported a leak large enough to cause a loss of mechanical ventilation. There was no report of patient involvement.
 
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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
john szalinski
MDR Report Key11444881
MDR Text Key250610095
Report Number9710602-2021-00075
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 distributor,foreign,health pr
Type of Report Initial
Report Date 03/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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