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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE / DATEX-OHMEDA INC. ANESTHETIC VAPORIZER ; ANESTHETIC VAPORIZER

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GE HEALTHCARE / DATEX-OHMEDA INC. ANESTHETIC VAPORIZER ; ANESTHETIC VAPORIZER Back to Search Results
Model Number TEC 6 PLUS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abnormal Blood Gases (1034)
Event Date 05/09/2017
Event Type  Injury  
Event Description
High pco2 levels noted during cardiopulmonary bypass by poc blood gas analyzer.Values were rechecked with the same result.Perfusionist started troubleshooting the equipment.The vaporizer was replaced and values returned to normal.
 
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Brand Name
ANESTHETIC VAPORIZER
Type of Device
ANESTHETIC VAPORIZER
Manufacturer (Section D)
GE HEALTHCARE / DATEX-OHMEDA INC.
MDR Report Key6636313
MDR Text Key77524536
Report NumberMW5070353
Device Sequence Number1
Product Code CAD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/24/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTEC 6 PLUS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/09/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
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