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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. DATEX-OHMEDA ANESTHESIA DELIVERY UNIT GAS-MACHINE, ANESTHESIA

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DATEX-OHMEDA, INC. DATEX-OHMEDA ANESTHESIA DELIVERY UNIT GAS-MACHINE, ANESTHESIA Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 05/16/2016
Event Type  malfunction  
Event Description
The anesthesia machine failed intra-operatively.
 
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Brand NameDATEX-OHMEDA ANESTHESIA DELIVERY UNIT
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI 53718
MDR Report Key5784849
MDR Text Key49246331
Report Number5784849
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2016
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberVER. M1004742-8.0 28 APR 200
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2016
Device Age13 YR
Event Location Hospital
Date Report to Manufacturer06/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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