ADULT NASAL INTERFACE OPT944

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-17 for ADULT NASAL INTERFACE OPT944 manufactured by Fisher & Paykel Healthcare Ltd.

MAUDE Entry Details

Report Number9611451-2019-01216
MDR Report Key9484701
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-12-17
Date of Report2019-12-11
Date of Event2019-10-28
Date Mfgr Received2020-02-28
Date Added to Maude2019-12-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS FARANAK GOMAROONI
Manufacturer Street173 TECHNOLOGY DRIVE SUITE 100
Manufacturer CityIRVINE, CA CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9194534000
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 NameADULT NASAL INTERFACE
Generic NameCAT
Product CodeCAT
Date Received2019-12-17
Model NumberOPT944
Catalog NumberOPT944
Lot Number2100869718
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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
101. Required No Informationntervention 2019-12-17

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