TEC 7

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-07-07 for TEC 7 manufactured by Datex-ohmeda, Inc..

Event Text Entries

[79272571] The ge healthcare service representative replaced the vaporizer to resolve the issue.
Patient Sequence No: 1, Text Type: N, H10


[79272572] During a planned maintenance visit, ge healthcare service representative noted two vaporizers could turn on simultaneously. There was no report of patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2112667-2017-01248
MDR Report Key6693125
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-07-07
Date of Report2017-07-07
Date of Event2017-06-13
Date Mfgr Received2017-06-13
Device Manufacturer Date2011-02-01
Date Added to Maude2017-07-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactJOSEPH SELIGA
Manufacturer Street3000 N GRANDVIEW BLVD.
Manufacturer CityWAUKESHA WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTEC 7
Generic NameVAPORIZER
Product CodeCAD
Date Received2017-07-07
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDATEX-OHMEDA, INC.
Manufacturer Address3030 OHMEDA DR, MADISON, WI US


Patients

Patient NumberTreatmentOutcomeDate
10 2017-07-07

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