ADULT NASAL INTERFACE OPT844

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-23 for ADULT NASAL INTERFACE OPT844 manufactured by Fisher & Paykel Healthcare Ltd.

Event Text Entries

[182975533] (b)(4). The opt844 interface is not returning to fisher & paykel healthcare (f&p) for evaluation. We are currently in process to obtain further information 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


[182975554] A distributor in (b)(6) on behalf of a healthcare facility reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt844 nasal cannula was leaking gas during use. There was no reported patient consequences.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611451-2020-00090
MDR Report Key9623416
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-01-23
Date of Report2019-12-24
Date of Event2019-11-20
Date Mfgr Received2020-02-17
Device Manufacturer Date2019-04-30
Date Added to Maude2020-01-23
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 DRIVE SUITE 100
Manufacturer CityIRVINE 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 Received2020-01-23
Model NumberOPT844
Catalog NumberOPT844
Lot Number2100758235
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
10 2020-01-23

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