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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7900; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. AESTIVA 7900; ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1006-9305-000
Device Problems Infusion or Flow Problem (2964); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
Customer contact reports no patient information available.A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The sodasorb canister was replaced to resolve the reported issue.
 
Event Description
The hospital reported that a valve was sticking resulting in the machine losing manual ventilation.There was no report of patient injury.
 
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Brand Name
AESTIVA 7900
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 Key9531940
MDR Text Key219217233
Report Number2112667-2019-02754
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 12/30/2019
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
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
Initial Date Manufacturer Received 12/04/2019
Initial Date FDA Received12/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2008
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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