MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AUTOFILL CHAMBER; BTT

Model Number 900PT290E

Device Problem Crack (1135)

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

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) has requested for the complaint device be returned for evaluation.We will provide a follow up report upon completion of our investigation.Product background: the 900pt290e autofill chamber with adapter (900pt290e) 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.

Event Description

A distributor reported on behalf of a healthcare facility in china that a 900pt290e autofill chamber with adapter was found with a chamber crack before use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

Manufacturer Narrative

(b)(4).Product background: the 900pt290e autofill chamber with adapter (900pt290e) 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.Method: the complaint 900pt290e was received at fisher & paykel healthcare (f&p) for investigation, where it was visually inspected.Results: visual inspection of the returned 900pt290e revealed a crack on the dome of the chamber.There was also damage to the chamber base.Conclusion: our investigation was unable to determine the cause of the observed damage to the 900pt290e.Based on our knowledge of the product it is likely due to the chamber being subjected to an external force.Every 900pt290e is visually inspected and pressure tested throughout the manufacturing process to check for any leaks and cracks.Any chamber that fails this inspection is rejected.The subject chamber would have met the required specification at the time of production.Our user instructions that accompany the 900pt290e as part of the 900pt561 heated breathing tube and chamber kit state the following: "for single patient use only.Reuse may result in transmission of infectious substances.Attempting to reprocess will result in degradation of materials and render the product defective." "do not use the auto-fill chamber if it has been dropped or been allowed to run dry." "do not use the chamber if the water level rises above the maximum water level line." "avoid contact with chemicals, cleaning agents, or hand sanitizers.".

Event Description

A distributor reported on behalf of a healthcare facility in china that a 900pt290e autofill chamber with adapter was found with a chamber crack before use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• Brand Name: AUTOFILL CHAMBER
• Type of Device: BTT
• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 16631868
• MDR Text Key: 312433126
• Report Number: 9611451-2023-00279
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012433794
• UDI-Public: (01)09420012433794(10)2102048736(11)220223
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

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
• Device Operator: Health Professional
• Device Model Number: 900PT290E
• Device Catalogue Number: 900PT290E
• Device Lot Number: 2102048736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2022
• 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 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT.; F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT.