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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE 7100; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. AESPIRE 7100; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Date 12/21/2015
Event Type  malfunction  
Manufacturer Narrative
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.A ge healthcare field engineer performed a checkout of the equipment and confirmed the reported complaint.The needle valve was replaced and the link 25 hypoxic guard adjusted; the unit was returned to service.
 
Event Description
The hospital reported the unit was not passing the hypoxic test, the o2 being delivered in 19%.There was no report of patient involvement.
 
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Brand Name
AESPIRE 7100
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI 53718
Manufacturer Contact
joseph seliga
3000 n grandview blvd.
waukesha, WI 53188
MDR Report Key5338008
MDR Text Key34767477
Report Number2112667-2015-00519
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 foreign,health professional,u
Type of Report Initial
Report Date 12/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2015
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 Received12/21/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2012
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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