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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. TEC 7; VAPORIZER
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DATEX-OHMEDA, INC. TEC 7; VAPORIZER Back to Search Results
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/14/2018
Event Type  malfunction  
Manufacturer Narrative
The hospital biomed tested the unit and found it to fail the low pressure leak test.The vaporizer was replaced.Patient information could not be obtained after multiple attempts.Attempts were made as follows: 07/30/18 phone call, 08/07/18 phone call, 08/08/18 phone call.
 
Event Description
The hospital reported that, during a case, higher than expected level of carbon dioxide was noted.Clinician reportedly had to increase level of anesthetic agent to maintain level of anesthesia.There was no reported patient injury.
 
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Brand Name
TEC 7
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 Key7772026
MDR Text Key116725180
Report Number2112667-2018-01585
Device Sequence Number1
Product Code CAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012924
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2010
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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