OPTIFLOW JUNIOR INTERFACE OPT314

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 2020-01-08 for OPTIFLOW JUNIOR INTERFACE OPT314 manufactured by Fisher & Paykel Healthcare Ltd.

Event Text Entries

[182343783] (b)(4). The opt314 optiflow junior cannula was received at fisher & paykel healthcare in (b)(4) but evaluation has not yet begun. We are also in process to obtain further iformation from the customer to determine if f&p's product caused or contributed to the reported event. We will provide a follow up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10


[182343784] A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that the tube was broken from the connector of an opt314 optiflow junior nasal cannula during use. There was no patient consequences.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611451-2020-00034
MDR Report Key9567219
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-08
Date of Report2019-12-10
Date of Event2019-12-05
Date Mfgr Received2020-02-24
Date Added to Maude2020-01-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 NameOPTIFLOW JUNIOR INTERFACE
Generic NameCAT
Product CodeCAT
Date Received2020-01-08
Returned To Mfg2020-01-09
Model NumberOPT314
Catalog NumberOPT314
Lot NumberNOT PROVIDED
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2020-01-08

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