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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7100; ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AESTIVA 7100; ANESTHESIA GAS MACHINE Back to Search Results
Device Problems Loss of Power (1475); Reset Problem (3019)
Patient Problem No Patient Involvement (2645)
Event Date 04/06/2016
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement.Initial reporter: the initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare's investigation is ongoing.A follow up-report will be submitted once the investigation has been completed.
 
Event Description
The hospital reported the unit had a system reset error that caused the unit to shutdown automatically.There is no report of patient involvement.
 
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The control board was replaced and the unit was returned to service.
 
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Brand Name
AESTIVA 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
brad wheeler
3000 n. grandview blvd., w450
waukesha, WI 53188
MDR Report Key5637384
MDR Text Key44999533
Report Number2112667-2016-00860
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,Followup
Report Date 06/29/2016
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
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/06/2016
Initial Date FDA Received05/06/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
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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