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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
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 11/23/2017
Event Type  malfunction  
Manufacturer Narrative
(no report of patient involvement.(b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The flow sensor was replaced, and the unit was returned to service.
 
Event Description
The hospital reported inaccurate monitoring as a result of the mylar flap of the flow sensor stuck to the top of the flow sensor housing.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
Manufacturer Contact
joseph seliga
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7135277
MDR Text Key95517806
Report Number2112667-2017-02371
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K050626
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 12/20/2017
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
Other Device ID NumberSEE H10
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/23/2017
Initial Date FDA Received12/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2016
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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