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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX OHMEDA, INC. SEVOTEC 5 GAS MACHINE ANESTHESIA

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DATEX OHMEDA, INC. SEVOTEC 5 GAS MACHINE ANESTHESIA Back to Search Results
Device Problems Defective Component (2292); Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2019
Event Type  malfunction  
Event Description
It was reported that the vaporizer unlocked during surgery, ceased to function properly. Fda safety report id# (b)(4).
 
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Brand NameSEVOTEC 5
Type of DeviceGAS MACHINE ANESTHESIA
Manufacturer (Section D)
DATEX OHMEDA, INC.
MDR Report Key9295586
MDR Text Key166187644
Report NumberMW5090972
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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