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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. TEC 6 PLUS; VAPORIZER

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DATEX-OHMEDA, INC. TEC 6 PLUS; VAPORIZER Back to Search Results
Device Problem Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2018
Event Type  malfunction  
Manufacturer Narrative
A gehc service representative performed a checkout of the equipment.The vaporizer was replaced.
 
Event Description
The hospital reported that, during a case, higher than expected anesthetic agent output was noted.The clinician reportedly switched to a different anesthetic agent to complete the case.There was no reported patient injury.
 
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Brand Name
TEC 6 PLUS
Type of Device
VAPORIZER
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7740459
MDR Text Key115906486
Report Number2112667-2018-01523
Device Sequence Number1
Product Code CAD
Combination Product (y/n)N
PMA/PMN Number
K000275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 08/01/2018
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 07/19/2018
Initial Date FDA Received08/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2013
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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