VENTED AUTOFEED HUMIDIFICATION CHAMBER MR290V

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-30 for VENTED AUTOFEED HUMIDIFICATION CHAMBER MR290V manufactured by Fisher & Paykel Healthcare Ltd.

MAUDE Entry Details

Report Number9611451-2019-01146
MDR Report Key9392242
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-30
Date of Report2019-10-31
Date of Event2019-10-28
Date Mfgr Received2019-10-31
Device Manufacturer Date2019-07-13
Date Added to Maude2019-11-30
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 ContactMS. FARANAK GOMAROONI
Manufacturer Street173 TECHNOLOGY DR. SUITE 100
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9494534000
Manufacturer G1FISHER & PAYKEL HEALTHCARE LTD
Manufacturer Street15 MAURICE PAYKEL PLACE EAST TAMAKI
Manufacturer CityAUCKLAND, 2013
Manufacturer CountryNZ
Manufacturer Postal Code2013
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVENTED AUTOFEED HUMIDIFICATION CHAMBER
Generic NameAUTOFEED CHAMBER
Product CodeBTT
Date Received2019-11-30
Model NumberMR290V
Catalog NumberMR290V
Lot Number190713
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerFISHER & PAYKEL HEALTHCARE LTD
Manufacturer Address15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-30

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.