MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + ADULT NASAL CANNULA

Model Number	OPT944
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).E1: (b)(6).Fisher & paykel healthcare (f&p) has requested for the complaint device to be returned for evaluation.F&p will provide a follow up report upon completion of f&p's investigation.Product background: the opt946 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.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 the united kingdom reported that the tubing of an opt944 optiflow + adult nasal cannula was found detached from the 3-way connector during use.There were no reported patient consequences.
Event or Problem Description
A healthcare facility in the united kingdom reported that the tubing of an opt944 optiflow + adult nasal cannula was found detached from the 3-way connector during use.Upon request for further information, the healthcare facility stated that it is unlikely that the subject opt944 optiflow + adult nasal cannula was pulled.The healthcare facility further stated that the opt944 optiflow + adult nasal cannula could have been caught or stuck on the equipment while moving the patient.There was no patient consequences.
Additional Manufacturer Narrative
(b)(4).Corrected data: b4, b5, d9, g3, g6, h2, h6, h11.E1: the full address is (b)(6).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.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 complaint opt944 optiflow + adult nasal cannula was received at f&p in new zealand for investigation, where it was visually inspected.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 opt944 optiflow + adult nasal cannula revealed that the tubing was the tubing of the opt944 optiflow + adult nasal cannula was detached from the 3-way connector.The tubing of the subject device was found to be slightly stretched near the 3-way connector and near the manifold.Visual inspection of the subject device also revealed that the nasal prongs on the right side was detached from the manifold.There were no patient consequences reported by the healthcare facility.Upon request for further information, the healthcare facility stated that it is unlikely that the subject opt944 optiflow + adult nasal cannula was pulled.The healthcare facility further stated that the opt944 optiflow + adult nasal cannula could have been caught or stuck on the equipment while moving the patient.Conclusion: f&p's investigation was unable to determine the cause of the observed damage to the opt944 optiflow + adult nasal cannula.Based on f&p's knowledge of the product the tubing was likely subjected to excessive force.Manufacturing controls include inspections during production for visual defects to the optiflow + tubing and the swivel, including cracks, tears, moulding defects, contamination, inclusions, discoloration and stretching or deformation.The optiflow + tubing is also inspected for any assembly defects, including confirmation the swivel and 3-way connector are connected with the correct engagement.The subject opt944 optiflow + adult nasal cannula would have met the required specifications.The user instructions which accompany the opt944 optiflow + adult 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: OPTIFLOW + ADULT NASAL CANNULA
• 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: 23861584
• Report Number: 9611451-2025-02197
• Device Sequence Number: 9974622
• Product Code: BTT
• UDI-Device Identifier: 09420012429117
• UDI-Public: (01)09420012429117(10)2100979616(11)200113
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 2100979616
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2020
• 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 Age: 16 YR
• Patient Sex: Female