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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7900; ANETHESIA MACHINE
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DATEX-OHMEDA, INC. AESTIVA 7900; ANETHESIA MACHINE Back to Search Results
Model Number 1006-9305-000
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 03/07/2018
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare service representative 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.Date of device manufacture year is 2003.The month of manufacture was unavailable at time of mdr filing.
 
Event Description
The hospital reported the adjustable pressure limiting valve was broken causing an inability to manually ventilate.There was no report of patient involvement.
 
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Brand Name
AESTIVA 7900
Type of Device
ANETHESIA MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison WI 53718
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 53188
8479711808
MDR Report Key7403016
MDR Text Key104711867
Report Number2112667-2018-00706
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1006-9305-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/07/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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