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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 Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 08/06/2014
Event Type  malfunction  
Manufacturer Narrative
The unit was returned to the manufacturing site for investigation.The unit was inspected and it was noted that the plunger was not installed correctly.The mdr was filed following a retrospective review related to a 483 response.No report of patient involvement.
 
Event Description
The hospital reportedly noted that, during preuse testing, two vaporizers could turn on simultaneously.There was no report of patient involvement.
 
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Brand Name
TEC 7
Type of Device
VAPORIZER
Manufacturer (Section D)
DATEX-OHMEDA, INC
3030 ohmeda drive
madison WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC
3030 ohmeda drive
madison WI 53718
Manufacturer Contact
john szalinski
540 w. northwest highway
barrington, IL 60010-3076
8472774719
MDR Report Key5131613
MDR Text Key27942360
Report Number2112667-2015-00164
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
Report Date 08/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/06/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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