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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7100; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. AESTIVA 7100; ANESTHESIA GAS MACHINE Back to Search Results
Device Problems Mechanical Problem (1384); Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 11/02/2017
Event Type  malfunction  
Manufacturer Narrative
The distributor performed a checkout of the equipment and confirmed the reported complaint.The adjustable pressure limiting valve 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.The distributor performed a checkout of the equipment and confirmed the reported complaint.The adjustable pressure limiting valve was replaced, and the unit was returned to service.
 
Event Description
The hospital reported the adjustable pressure limiting valve was not working and preventing the use of manual ventilation.There was no report of patient involvement.
 
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Brand Name
AESTIVA 7100
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI
Manufacturer Contact
john szalinski
540 w. northwest highway
barrington, IL 
MDR Report Key7067304
MDR Text Key93487572
Report Number2112667-2017-02247
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 distributor,foreign,health pr
Type of Report Initial
Report Date 11/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2017
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 Received11/02/2017
Date Device Manufactured03/03/2009
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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