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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) AESPIRE 7100; ANESTHESIA GAS MACHINE

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GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) AESPIRE 7100; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Patient Involvement (2645)
Event Date 08/11/2018
Event Type  malfunction  
Manufacturer Narrative
The ge healthcare service representative performed a checkout of the equipment and confirmed the mylar flap of the flow sensors were stuck to the top of the flow sensor housing.The flow sensors was replaced, and the unit was returned to service.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.
 
Event Description
The hospital reported the tidal volume is not being displayed accurately.There was no report of patient involvement.
 
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Brand Name
AESPIRE 7100
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 Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7856058
MDR Text Key119803607
Report Number9710602-2018-00227
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K000706
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 09/07/2018
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? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/11/2018
Initial Date FDA Received09/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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