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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 Improper Flow or Infusion (2954)
Patient Problem No Patient Involvement (2645)
Event Date 03/12/2020
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.Unique identifier: (b)(4).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.Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported an error the oxygen proportioning system resulting in a hypoxic mix in the patient circuit.There was no report of patient involvement.
 
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The balance regulator was replaced to resolve the reported issue.
 
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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 Key9947886
MDR Text Key187944658
Report Number9710602-2020-00129
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 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 03/12/2020
Initial Date FDA Received04/10/2020
Supplement Dates Manufacturer Received04/16/2020
Supplement Dates FDA Received04/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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