IVENT 201 M1163923

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-29 for IVENT 201 M1163923 manufactured by Datex-ohmeda, Inc..

MAUDE Entry Details

Report Number2112667-2019-02396
MDR Report Key9391990
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-01
Date Mfgr Received2019-11-01
Device Manufacturer Date1970-01-01
Date Added to Maude2019-11-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJOHN SZALINSKI
Manufacturer CityWI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIVENT 201
Generic NameCRITICAL CARE VENTILATER
Product CodeCBK
Date Received2019-11-29
Model NumberM1163923
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDATEX-OHMEDA, INC.
Manufacturer Address3030 OHMEDA DR, MADISON, WI 53718 US 53718


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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