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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 Suction Problem (2170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2023
Event Type  malfunction  
Event Description
It was reported that there was a malfunction resulting in loss of suction.There was no patient involvement.
 
Manufacturer Narrative
Ge healthcareâs investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Block a: no report of patient involvement.Block e1: the initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Block d4 unique identifier: (b)(4).Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718 h3: device evaluation anticipated, but not yet begun.
 
Manufacturer Narrative
Additional information was received that the unit was able to provide maximum suction.There was no reportable malfunction.
 
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Brand Name
CARESTATION 650
Type of Device
ANESTHESIA 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 Key17009146
MDR Text Key316004534
Report Number9710602-2023-00506
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeSW
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 06/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/17/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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