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

Model Number	900PT561
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Fisher & paykel healthcare (f&p) has requested for the complaint device be returned for evaluation.F&p will provide a follow up report upon completion of f&p's 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.
Event or Problem Description
A healthcare facility in taiwan reported via a fisher and paykel healthcare (f&p) field representative that the autofill chamber as a part of the 900pt561 heated breathing tube and chamber kit was found damaged before patient use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
Event or Problem Description
A healthcare facility in taiwan reported via a fisher and paykel healthcare (f&p) field representative that the autofill chamber as a part of the 900pt561 heated breathing tube and chamber kit was found damaged before patient use.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
Additional Manufacturer Narrative
(b)(4).Corrected data: b4, d9, g3, g6, h2, h3, h6.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.Method: the subject autofill chamber as part of the 900pt561 heated breathing tube and chamber kit was received at fisher & paykel healthcare (f&p) new zealand where it was visually inspected.Results: visual inspection of the subject autofill chamber revealed that there was no damage.The chamber adapter as part of the 900pt561 heated breathing tube and chamber kit was returned alongside the subject autofill chamber.The chamber adapter was observed to be broken into two pieces.Conclusion: fisher & paykel healthcare (f&p) were unable to determine what may have caused the reported failure as there was no fault found with the returned subject autofill chamber as part of the 900pt561 heated breathing tube and chamber kit.It is possible that the healthcare facility was referring to the damage to the chamber adapter in their initial report.The chamber adapter was observed to be broken into two pieces which would prevent the user from setting up the device.The healthcare facility stated that there was no patient involvement as the issue was found whilst the device was not in use on a patient.The chamber adapter as part of the 900pt561 heated breathing tube and chamber kit is a separate component of the kit that allows for the autofill chamber to be used with the airvo 2 humidification series.Every autofill chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber.Any chamber that fails this test is rejected.The user instructions that accompany the 900pt561 heated breathing tube and chamber kit state the following: - "do not use the autofill chamber if it has been dropped or been allowed to run dry as this could lead to the chamber over-filling." - "do not use the autofill chamber if the water level rises above the maximum water level line as this may lead to water entering the patient's airway." - "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." - "avoid contact with chemicals, cleaning agents, or hand sanitizers.".

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: 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: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 22154782
• Report Number: 9611451-2025-00498
• Device Sequence Number: 8906756
• Product Code: BTT
• UDI-Device Identifier: 09420012433794
• UDI-Public: (01)09420012433794(10)2103589514(11)250124
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: Health Professional
• Device Model Number: 900PT561
• Device Catalogue Number: 900PT561
• Device Lot Number: 2103589514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: F&P PT101 AIRVO 2 HUMIDIFIER; F&P PT101 AIRVO 2 HUMIDIFIER
• Patient Sex: Unknown