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

Model Number	OPT964
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in canada reported, via a fisher and paykel healthcare (f&p) field representative, that an opt964 optiflow + duet asymmetrical nasal cannula was found to be damaged and leaking air during use.There were no patient consequences.
Additional Manufacturer Narrative
(b)(6).Fisher & paykel healthcare (f&p) has requested for the complaint device to be returned for evaluation, and for further information regarding the reported event.F&p will provide a follow-up report upon completion of the investigation.Product background: the opt964 optiflow + duet asymmetrical 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 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 healthcare facility in canada reported, via a fisher and paykel healthcare (f&p) field representative, that an opt964 optiflow + duet asymmetrical nasal cannula was found to be damaged and leaking air during use.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Corrected data: b4, d9, g3, g6, h2, h3, h6, h11.Product background: the opt964 optiflow + asymmetrical 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 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 opt964 optiflow + asymmetrical 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 opt964 optiflow + asymmetrical nasal cannula revealed that the tubing was torn near the headgear clip.There were no patient consequences reported by the healthcare facility.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, the type of damaged observed from f&p's observation that the tubing was stretched, 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 opt964 optiflow + asymmetrical nasal cannula would have met the required specifications.The user instructions which accompany the opt964 optiflow + asymmetrical nasal cannula show in pictorial format the correct placement and fitting of the cannula, including ensuring the head strap clip and the tubing clip are appropriately attached.The user instructions also state: - "do not crush or stretch tube, to prevent loss of therapy." - "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." - "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death." - "failure to use the set-up described above can compromise performance and affect patient safety.".

• 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 23493860
• Report Number: 9611451-2025-01310
• Device Sequence Number: 13010117
• Product Code: BTT
• UDI-Device Identifier: 09420012469564
• UDI-Public: (01)09420012469564(10)2103526476(11)241210
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K231956
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: OPT964
• Device Catalogue Number: OPT964
• Device Lot Number: 2103526476
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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