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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 Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 04/27/2018
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare¿s 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.Date of device manufacture was unavailable at time of mdr filing.Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported that thev unit is not working properly.There is a leak greater than 500ml/min.There was no report of patient involvement.
 
Manufacturer Narrative
Additional information was received stating that the leak rate was less than 4.5 lpm.There was no loss of manual or mechanical ventilation.This was not a reportable malfunction.Additional information was received stating that the leak rate was less than 4.5 lpm.There was no loss of manual or mechanical ventilation.This was not a 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
CH 
MDR Report Key7544411
MDR Text Key109251996
Report Number9710602-2018-00136
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 user facility
Type of Report Initial,Followup
Report Date 08/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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