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

Model Number OPT944

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 our investigation.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 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.

Event Description

A distributor reported on behalf of a healthcare facility in japan via a fisher and paykel healthcare (f&p) field representative that the tubing of an opt944 optiflow + adult nasal cannula was found damaged during patient use.There were no reported patient consequences.

• Brand Name: OPTIFLOW + ADULT NASAL CANNULA
• Type of Device: 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 19029806
• MDR Text Key: 339239368
• Report Number: 9611451-2024-00266
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2024

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
• Device Operator: Health Professional
• Device Model Number: OPT944
• Device Catalogue Number: OPT944
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: F&P 950 RESPIRATORY HUMIDIFIER; F&P 950N81 DUAL HEATED BREATHING CIRCUIT KIT