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

Model Number	OPT942
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The healthcare facility reported that the subject opt942 optiflow + adult nasal cannula was discarded.Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.F&p will provide a follow up report upon completion of our investigation.
Event or Problem Description
On 7 october 2024 a healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that on (b)(6) 2024 the manifold of a opt942 optiflow + adult nasal cannula had become disconnected from the patient interface during use.The healthcare facility further reported that the patient was settled when they were seen by a staff member at 5:30pm and that at 6pm they were found unresponsive and that the opt942 optiflow + adult nasal cannula was disconnected at the manifold.It was further reported that the patient passed away and the cause of death was food aspiration in combination with bronchopneumonia and that they also had systemic hypertension and chronic leg ulcers.The healthcare facility also stated that its telemetry was not working and the patient was on amber care and had a dnar in place.
Event or Problem Description
On 7 october 2024 a healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that on (b)(6) 2024 the manifold of a opt942 optiflow + adult nasal cannula had become disconnected from the patient interface during use.The healthcare facility further reported that the patient was settled when they were seen by a staff member at 5:30pm and that at 6pm the patient was found unresponsive and that the opt942 optiflow + adult nasal cannula was disconnected at the manifold.It was further reported that the patient passed away and the cause of death was food aspiration in combination with bronchopneumonia and that they also had systemic hypertension and chronic leg ulcers.It was also reported that the patient was on amber care and had a dnar order in place.There was no patient monitoring in place as the healthcare facility reported that its telemetry was not working.
Additional Manufacturer Narrative
(b)(4).Product background: the opt942 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 healthcare facility reported that the subject opt942 optiflow + adult nasal cannula had been discarded and thus could not be returned to f&p for evaluation.F&p's investigation is therefor based on the information and photograph provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the photograph provided by the healthcare facility showed that the manifold had disconnected from the nasal prong connection of the patient interface.There was no damage to the manifold or nasal prongs observed from the photograph.The healthcare facility further reported that the patient was settled when they were seen by a staff member at 5:30pm and that at 6pm the patient was found unresponsive and that the opt942 optiflow + adult nasal cannula manifold was disconnected from the patient interface.It was further reported that the patient passed away and the cause of death was food aspiration in combination with bronchopneumonia and that they also had systemic hypertension and chronic leg ulcers.It was also reported that the patient was on amber care and had a dnar order in place.There was no patient monitoring in place as the healthcare facility reported that its telemetry was not working.Conclusion: our investigation was unable to determine the cause of the disconnection between the manifold and the nasal prong connection.There was no visible damage to the subject device in the photograph provided.The user instructions which accompany the opt942 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: "appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death." "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." "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." 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 opt942 optiflow + adult nasal cannula would have met the required specifications.

• 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: 20616623
• Report Number: 9611451-2024-00800
• Device Sequence Number: 7453117
• Product Code: BTT
• UDI-Device Identifier: 09420012428493
• UDI-Public: (01)09420012428493(10)2101387215(11)201113
• 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,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: OPT942
• Device Catalogue Number: OPT942
• Device Lot Number: 2101387215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2020
• 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: 74 YR
• Patient Sex: Unknown