MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD HEATED BREATHING TUBE AND CHAMBER KIT; AUTOFILL CHAMBER

Model Number 900PT561

Device Problem Crack (1135)

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

Event Date 02/09/2024

Event Type  malfunction  

Event Description

A distributor reported in russia via a fisher and paykel healthcare (f&p) field representative that the autofill chamber as part of the 900pt561 heated breathing tube and chamber kit was found with a chamber damaged at the base.There were no patient consequences.

Manufacturer Narrative

(b)(6).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.Product background: the autofill chamber as part of 900pt561 heated breathing tube and chamber kit is a component designed for use with the airvo 2 humidification series to provide nasal high flow (nhf) therapy.Air and oxygen are blown from the airvo 2 into the humidification chamber within which water is heated by a heater plate.The gases become humidified in the chamber and then pass into a heated breathing tube, then to the patient interface.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.

• Brand Name: HEATED BREATHING TUBE AND CHAMBER KIT
• Type of Device: AUTOFILL CHAMBER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 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: 18862859
• MDR Text Key: 337183200
• Report Number: 9611451-2024-00186
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900PT561
• Device Catalogue Number: 900PT561
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2024
• 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: 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT; PT101 AIRVO 2 HUMIDIFIER