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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 Inaccurate Delivery (2339)
Patient Problem Insufficient Information (4580)
Event Date 07/12/2022
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. 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)(6). Legal manufacturer: (b)(4).
 
Event Description
The customer reported a malfunction found during pre-use checkout which may result in a delivery of a hypoxic gas mixture. 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 (Section G)
GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
no. 19 changjiang road
national hi-tech dev. zone
wuxi 21402 8
CH 214028
Manufacturer Contact
anthony amenson
MDR Report Key15197494
MDR Text Key303047064
Report Number9710602-2022-00444
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K151570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 09/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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