MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD MYAIRVO OPTIFLOW + NASAL CANNULA; BTT

Model Number	MYOPT9MEDIUM
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product background: the myopt9medium myairvo optiflow + 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.Myairvo optiflow + nasal cannula are designed for use with the myairvo series humidifiers to provide nhf.Nhf therapy is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases nhf therapy should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the complaint myopt9medium myairvo optiflow + nasal cannula was received at fisher & paykel healthcare (f&p) in new zealand for investigation, where it was visually inspected.Our investigation is based on our evaluation of the subject device, information provided by the distributor, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the myopt9medium myairvo optiflow + nasal cannula revealed that the tubing was damaged near the centre of the tube's length.The film of the tubing was torn and one of the spirals is deformed which indicated that there was an external force being applied to the tubing.There were no patient involvement reported by the distributor.Conclusion: our investigation was unable to determine the cause of the observed damage to the myopt9medium myairvo optiflow + nasal cannula.Based on our knowledge of the product the tubing was likely subjected to excessive force before patient use.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 myopt9medium myairvo optiflow + 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 that the tubing of an myopt9medium myairvo optiflow + nasal cannula was found damaged before use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• Brand Name: MYAIRVO OPTIFLOW + NASAL CANNULA
• Common Device Name: BTT
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17447489
• Report Number: 9611451-2023-00712
• Device Sequence Number: 7383373
• Product Code: BTT
• UDI-Device Identifier: 09420012469687
• UDI-Public: (01)09420012469687(10)2102097489(11)220324
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/04/2023

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: Lay User/Patient
• Device Model Number: MYOPT9MEDIUM
• Device Catalogue Number: MYOPT9MEDIUM
• Device Lot Number: 2102097489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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