ENGSTROM

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 2020-03-30 for ENGSTROM manufactured by Datex-ohmeda, Inc..

MAUDE Entry Details

Report Number2112667-2020-01062
MDR Report Key9897295
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-03
Date Mfgr Received2020-03-03
Device Manufacturer Date2009-03-31
Date Added to Maude2020-03-30
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 Street3000 N GRANDVIEW BLVD.
Manufacturer CityWAUKESHA WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENGSTROM
Generic NameCRITICAL CARE VENTILATER
Product CodeCBK
Date Received2020-03-30
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 2020-03-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.