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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE 7900; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. AESPIRE 7900; ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1009-9012-000
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 12/27/2017
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement.The date of manufacture was not available at the time of filing.A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The cable from the flow sensor to the sensor interface board was reseated, and the unit was returned to service.
 
Event Description
The hospital reported the unit lost the ability to mechanically ventilate.There was no report of patient involvement.
 
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Brand Name
AESPIRE 7900
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison WI 53718
Manufacturer Contact
joseph seliga
3000 n grandview blvd.
waukesha, WI 53188
2625443620
MDR Report Key7219698
MDR Text Key98297638
Report Number2112667-2018-00203
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050626
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 01/25/2017
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
Device Model Number1009-9012-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/27/2017
Initial Date FDA Received01/25/2018
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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