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

Model Number OPT980

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It was reported by the healthcare facility that the subject device was discarded.Fisher & paykel healthcare (f&p) has requested additional information about the reported event including information about the patient condition and the level and duration of patient desaturation.We will provide a follow up report upon completion of our investigation.Product background: the opt980 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.The interface 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.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 healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that the tubing of an opt980 optiflow + mask interface adapter was found damaged during use.It was also reported that the patient had a period of desaturation at the time of the reported event and that the subject device was promptly replaced.No further patient consequences were reported.F&p has requested additional information about the reported event including information about the patient condition and the level and duration of patient desaturation.

• Brand Name: OPTIFLOW + MASK INTERFACE ADAPTER
• Type of Device: MASK INTERFACE ADAPTOR
• 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: 19169184
• MDR Text Key: 341417319
• Report Number: 9611451-2024-00312
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K162553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

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: OPT980
• Device Catalogue Number: OPT980
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/23/2024
• 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