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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 Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2022
Event Type  malfunction  
Manufacturer Narrative
The distributor performed a checkout of the equipment and confirmed the reported complaint. The needle air valve was replaced to resolve the 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)(6). Legal manufacturer: (b)(4). The distributor performed a checkout of the equipment and confirmed the reported complaint. The needle air valve was replaced to resolve the 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). Legal manufacturer: (b)(4).
 
Event Description
The hospital reported a malfunction causing a leak greater than 15lpm during pre-use checkout. 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 (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
3030 ohmeda drive
madison, WI 53718
MDR Report Key14496223
MDR Text Key300446593
Report Number9710602-2022-00201
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K151570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 05/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/30/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/04/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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