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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 Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 02/12/2016
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement.The unit was returned to the manufacturing site for investigation.The unit was tested, and the reported complaint was confirmed.It was further noted that the c-clip was missing from the pivot pin.A plunger, pivot pin, and c-clip were installed to correct the issue.
 
Event Description
The hospital reported that, during routine maintenance testing, the interlock system was not functioning.There was no report of patient involvement.
 
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Brand Name
TEC 6 PLUS
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
stephanie cass
3000 n. grandview boulevard
waukesha, WI 53188-1696
MDR Report Key5492682
MDR Text Key40085604
Report Number2112667-2016-00455
Device Sequence Number1
Product Code CAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K000275
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 03/10/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/12/2016
Initial Date FDA Received03/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2008
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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