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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE 7100; ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AESPIRE 7100; ANESTHESIA GAS MACHINE Back to Search Results
Device Problems Tidal Volume Fluctuations (1634); Device Operates Differently Than Expected (2913)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 06/08/2017
Event Type  malfunction  
Manufacturer Narrative
The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare¿s investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported the unit had inaccurate tidal volume.Patient use is currently unknown.
 
Manufacturer Narrative
Patient information could not be obtained due to country privacy laws.The ge healthcare service representative performed a checkout of the equipment and confirmed the mylar flap of the expiratory flow sensor was stuck to the top of the flow sensor housing.The flow sensor was replaced, and the unit was returned to service.
 
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Brand Name
AESPIRE 7100
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI
Manufacturer Contact
joseph seliga
3000 n grandview blvd.
waukesha, WI 
MDR Report Key6694368
MDR Text Key79398111
Report Number2112667-2017-01256
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,Followup
Report Date 07/12/2017
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 06/08/2017
Initial Date FDA Received07/07/2017
Supplement Dates Manufacturer Received06/08/2017
Supplement Dates FDA Received07/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
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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