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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 Excess Flow or Over-Infusion (1311); Tidal Volume Fluctuations (1634)
Patient Problem No Patient Involvement (2645)
Event Date 08/21/2018
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the equipment and was not able to confirm the reported complaint.The flow sensors were recommended for replacement 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.Date of device manufacture year is 2007.The month of manufacture was unavailable at time of mdr filing.
 
Event Description
The hospital reported the unit was over delivering tidal volume.There was no report of patient involvement.
 
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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 53718
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7890111
MDR Text Key120829489
Report Number2112667-2018-01845
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 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2018
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
Date Manufacturer Received08/22/2018
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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