MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW + MASK INTERFACE ADAPTER; BTT

Model Number	OPT980E
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A distributor reported on behalf of an end-user in (b)(6), via a fisher & paykel healthcare (f&p) representative, that the tubing of four opt980e optiflow + mask interface adapters were found damaged during use.There were no reported patient consequences.
Additional Manufacturer Narrative
Ps(b)(4).The opt980e optiflow + mask interface adapter is a patient interface used for delivery of humidified respiratory gases and allows for the connection of a heated breathing tube to a standard vented face mask or to a patient's tracheostomy.Optiflow + interfaces are designed for use with the airvo 2 series of humidification devices.The airvo 2 device is intended for use with spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 should not be used for life support purposes, and appropriate patient monitoring must be used at all times.The interface is held in place by a head strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's interface.Method: two of the four complaint opt980e optiflow + mask interface adapters were returned to fisher & paykel healthcare (f&p) new zealand for investigation, where they were visually inspected.Our investigation is based on the evaluation of the complaint devices, the information provided by the customer, and our knowledge of the product.Results: both devices were returned without the lanyard.The first device had medical tape around the mask adaptor end.After removing the tape, the tubing was found stretched and torn at the mask adaptor end.The second device had medical tape around the 3-way connector end.After removing the tape, the tubing was found stretched and torn at the 3-way connector end.The tubing was also stretched at the mask adaptor end.The customer reported that the lanyards were not used and that in one instance, one of the devices was used for 45 days.Conclusion: we are unable to determine the cause of the reported damage to the subject opt980e optiflow + mask interface adapters.However, based on our knowledge of the product and our observation that parts of the tubing of the returned cannulas appeared to have been stretched, the reported damage is likely to have been caused by the tubing being subjected to excessive force during use.It should be noted that the lanyard was not used to secure the cannulas and that one of the devices was used for 45 days.The user instructions which accompany the opt980e optiflow + mask interface adapter show in pictorial format the correct placement and fitting of the interface, including ensuring that the lanyard is appropriately worn, and warns: - "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." - "this product is intended to be used for a maximum of 30 days providing daily and weekly cleaning instructions are followed.".
Event or Problem Description
A distributor reported on behalf of an end-user in kansas, via a fisher & paykel healthcare (f&p) representative, that the tubing of four opt980e optiflow + mask interface adapters were found damaged during use.There were no reported patient consequences.

• Brand Name: OPTIFLOW + MASK INTERFACE ADAPTER
• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 13066493
• Report Number: 9611451-2021-01493
• Device Sequence Number: 11976501
• Product Code: BTT
• UDI-Device Identifier: 09420012436948
• UDI-Public: (01)09420012436948(10)2101602034(11)210511
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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: OPT980E
• Device Catalogue Number: OPT980
• Device Lot Number: 2101602034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 05/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• 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