OPTIFLOW THRIVE NASAL INTERFACE AA001M

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 2020-03-19 for OPTIFLOW THRIVE NASAL INTERFACE AA001M manufactured by Fisher & Paykel Healthcare Ltd.

Event Text Entries

[186284017] (b)(4). We are currently attempting to retrieve further information to determine any patient consequence and the involvement of our device in the reported event. We will provide a follow up report upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10


[186284018] A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a surgical fire occured while the aa001m optiflow thrive nasal interface was in use. The hospital reported that there was no defect with the f&p product that was in use at the time. We have requested further detail from the hospital. There was no reported patient consequences.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611451-2020-00294
MDR Report Key9858200
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-19
Date of Report2020-02-20
Date of Event2020-02-17
Date Mfgr Received2020-02-20
Date Added to Maude2020-03-19
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 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 NameOPTIFLOW THRIVE NASAL INTERFACE
Generic NameBTT
Product CodeBTT
Date Received2020-03-19
Model NumberAA001M
Catalog NumberAA001M
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
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 2020-03-19

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