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,distri report with the FDA on 2020-03-25 for ADULT NASAL INTERFACE OPT944 manufactured by Fisher & Paykel Healthcare Ltd.

Event Text Entries

[187785396] (b)(4). The opt944 interface is used to deliver humidified oxygen to patients and consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface). The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged. Method: the complaint cannula was not received at fisher & paykel healthcare for evaluation. Our investigation is thus based on the photographs provided by the customer. Results: visual inspection of the provided photograph revealed that the tubing was pulled apart next to the connector. Conclusion: the reported event is most likely caused by the tube being pulled by the patient. All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and stretching or deformation. Any product that fails the visual inspection is disposed of. The setup instructions in the user instructions which accompany the opt944 nasal cannula include the following steps: "ensure head strap clip is attached, to prevent cannula from being pulled out of the nares. " "cannula can become unattached if not used with the head strap clip. " "attach tubing clip to clothing/bedding to prevent cannula from pulling off face. " the user instructions also contain the following warnings/cautions: "do not crush or stretch tube, to prevent loss of therapy. " "failure to use the set-up described above can compromise performance and affect patient safety. "
Patient Sequence No: 1, Text Type: N, H10


[187785397] A distributor in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that an opt944 optiflow adult nasal cannula was ruptured near the cannula connected to the tubing. There was no reported patient consequence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611451-2020-00314
MDR Report Key9876700
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-25
Date of Report2020-02-24
Date Mfgr Received2020-02-24
Device Manufacturer Date2019-12-17
Date Added to Maude2020-03-25
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
Manufacturer CountryUS
Manufacturer Phone4534000142
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 Received2020-03-25
Model NumberOPT944
Catalog NumberOPT944
Lot Number2100968449
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-03-25

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