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 2020-01-22 for ADULT NASAL INTERFACE OPT844 manufactured by Fisher & Paykel Healthcare Ltd.

Event Text Entries

[183168600] (b)(4). The opt844 interface is used to deliver humidified oxygen to patients. The opt844 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface). The interface is held in place by a head strap and also includes a lanyard that is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's nares. Method: the complaint opt844 nasal cannula was returned to fisher & paykel healthcare (f&p) regional office in (b)(4) where the photographs of the damaged part were taken and the device was disposed of. Our investigation is based on the photographs provided by the regional office and our knowledge of the product. Result: visual inspection of the provided photographs revealed that the nasal prong at the left headgear connection point was broken. Conclusion: the damage observed was most likely due to overtightening of the head strap. All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation. Any product that fails the visual inspection is disposed of. The user instructions which accompany the opt844 cannula show in pictorial format the correct placement and fitting of the cannula and also warn: appropriate patient monitoring must be used at all times. Failure to monitor the patient may result in loss of therapy, serious injury or death. Do not crush or stretch tube.
Patient Sequence No: 1, Text Type: N, H10


[183168601] A distributor in (b)(6) reported on behalf of a healthcare facility, via a fisher & paykel healthcare (f&p) field representative, that the connector hook of an opt844 nasal cannula was found broken after few days of use. There was no reported patient consequence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611451-2020-00075
MDR Report Key9619484
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-01-22
Date of Report2019-12-27
Date Mfgr Received2019-12-27
Device Manufacturer Date2019-02-26
Date Added to Maude2020-01-22
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 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 NameADULT NASAL INTERFACE
Generic NameCAT
Product CodeCAT
Date Received2020-01-22
Model NumberOPT844
Catalog NumberOPT844
Lot Number2100711024
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 2020-01-22

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