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U.S. Department of Health and Human Services

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

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DATEX-OHMEDA, INC. AESTIVA MRI; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 04/12/2018
Event Type  malfunction  
Manufacturer Narrative
The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.The hospital denied service on this unit.The resolution is unknown.
 
Event Description
The hospital reported a failure of the unit to operate as expected.There is no report of patient involvement.
 
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Brand Name
AESTIVA MRI
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 Key7496358
MDR Text Key107691433
Report Number2112667-2018-00926
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K993410
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 05/08/2018
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? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/12/2018
Initial Date FDA Received05/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/05/2012
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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