MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; NASAL CANNULA

Model Number	OPT944
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing f&p's investigation.F&p will provide a follow up report upon completion of f&p's investigation.Product background: the opt944 optiflow + adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases, including those who are receiving nasal high flow therapy (nhf).The cannula consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).This allows the device to be light weight and durable.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.Optiflow + interfaces are designed for use with the airvo series humidifiers and are also compatible with the fisher & paykel healthcare (f&p) mr850 and 950 humidification system devices.Optiflow + interfaces are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.Optiflow + interfaces are not intended for life support and appropriate patient monitoring must be used at all times.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan via a fisher and paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found damaged during patient use.There were no patient consequences.
Additional Manufacturer Narrative
(b)(6).Corrected data: b4, d9, g3, g6, h2, h3, h6, h11.Product background: the opt944 optiflow + adult nasal cannula is a nasal cannula patient interface for delivery of humidified respiratory gases, including those who are receiving nasal high flow therapy (nhf).The cannula consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).This allows the device to be light weight and durable.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.Optiflow + interfaces are designed for use with the airvo series humidifiers and are also compatible with the fisher & paykel healthcare (f&p) mr850 and 950 humidification system devices.Optiflow + interfaces are intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.Optiflow + interfaces are not intended for life support and appropriate patient monitoring must be used at all times.Method: the subject opt944 optiflow + adult nasal cannula was received at fisher & paykel healthcare (f&p) new zealand where it was visually inspected by a trained f&p investigation engineer.F&p's investigation is based on f&p's evaluation of the subject device, information provided by the healthcare facility, previous investigations of similar complaints, and f&p's knowledge of the product.Results: visual inspection of the subject opt944 optiflow + adult nasal cannula revealed that the tubing was torn near the 3-way connector, and at a section along the tubing.Upon f&p's request for further information, the healthcare facility reported that the provided clips to secure the subject device were not used.It was further reported by the healthcare facility that it may be possible that the subject device was pulled as the clips were not used.The healthcare facility reported no patient consequences.Conclusion: f&p's investigation was unable to determine the exact cause of the reported damage.Based on f&p's knowledge of the product, further information provided by the healthcare facility and the type of damaged observed, the tubing was likely subjected to excessive force.F&p's manufacturing controls for the optiflow + tubing include inspections during production for visual defects including cracks, tears, moulding defects, contamination, inclusions, discoloration and stretching or deformation.The subject opt944 optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the optiflow + interfaces for japan set out how the cannula should be placed and fitted, including the use of the head strap clip.The user instructions for japan also state the following: - "do not pull, squeeze, crush, or strongly pinch the breathing tube until the tube is deformed".- "it is recommended to use appropriate patient monitoring with this product ".- "fit the prongs to the patient's nose and secure it to the patient with the head strap.Make sure that the clip is secured to the head strap".- "make sure that an air flow is coming out of the prongs when using the product in the patient".- "use the clip to secure the tube to the prongs.".
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan via a fisher and paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found damaged during patient use.There were no patient consequences.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: NASAL CANNULA
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA ; 9494341005
• MDR Report Key: 24142906
• Report Number: 9611451-2026-00317
• Device Sequence Number: 8902915
• Product Code: BTT
• UDI-Device Identifier: 09420012429117
• UDI-Public: (01)09420012429117(10)2103509019(11)241204
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OPT944
• Device Catalogue Number: OPT944
• Device Lot Number: 2103509019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown