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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 Problems Leak/Splash (1354); Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 03/21/2016
Event Type  malfunction  
Manufacturer Narrative
A 3rd party service representative performed a checkout of the equipment and confirmed the reported complaint.The bag/vent micro-switch was replaced, and the unit was returned to service.
 
Event Description
The hospital reported a failure where the bag/vent switch leaked and failed to switch to mechanical ventilation during pre-use checkout.There is 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 (Section G)
GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)
no. 19 changjiang road
national hi-tech dev. zone
wuxi 21402 8
CH   214028
Manufacturer Contact
stephanie cass
3000 n. grandview boulevard
waukesha, WI 53188-1696
MDR Report Key5590578
MDR Text Key43123913
Report Number9710602-2016-00014
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 04/20/2016
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 03/21/2016
Initial Date FDA Received04/20/2016
Date Device Manufactured07/20/2010
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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