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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 Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/30/2020
Event Type  malfunction  
Manufacturer Narrative
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.(b)(4).Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.
 
Event Description
The hospital reported a flow sensor malfunction causing a loss of mechanical ventilation during a case.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 flow control valve and sensor interface board were replaced to resolve the issue.
 
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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
MDR Report Key10913755
MDR Text Key219380806
Report Number9710602-2020-00380
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 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2020
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 Received12/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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