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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 Energy Output Problem (1431)
Patient Problem No Patient Involvement (2645)
Event Date 12/05/2019
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The pop-off valve and the ventilator engine diaphragm assembly were replaced to resolve the reported issue.No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not unique identifier: (b)(4).
 
Event Description
The hospital reported a malfunction of the bellows causing a loss of mechanical ventilation.There was no report of patient involvement.
 
Manufacturer Narrative
Additional information was received from the ge healthcare field engineer that manual and mechanical ventilation were not affected by the reported event.The initial report was not reportable.H3 other text : additional information was received from the ge healthcare field engineer that manual and mechanical ventilation were not affected by the reported event.The initial report was not reportable.
 
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Brand Name
CARESTATION 620
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
MDR Report Key9537937
MDR Text Key188115039
Report Number9710602-2020-00004
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
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 Received01/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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