MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD HEATED BREATHING TUBE AND CHAMBER KIT; 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)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that the autofill chamber as part of the 900pt561 heated breathing tube and chamber kit was found with a chamber crack and leaking during patient use.There were no patient consequences.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china that the autofill chamber as part of the 900pt561 heated breathing tube and chamber kit was found with a chamber crack and leaking during patient use.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Corrected data:g1,g3,g6,h2,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 complaint autofill chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photograph provided by the healthcare facility, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the provided photograph revealed a vertical crack on the side of the autofill chamber dome.Additionally, the healthcare facility reported that the chamber was leaking water.Conclusion: without the return of the complaint device, we are unable to confirm the cause of the reported event.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 subject chamber would have met the required specification at the time of production.Our user instructions that accompany the 900pt561 heated breathing tube and chamber "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: HEATED BREATHING TUBE AND CHAMBER KIT
• 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 ba ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 19038919
• Report Number: 9611451-2024-00270
• Device Sequence Number: 7242397
• Product Code: BTT
• UDI-Device Identifier: 09420012433794
• UDI-Public: (01)09420012433794(10)2102084761(11)220316
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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
• Operator of Device: Health Professional
• Device Model Number: 900PT561
• Device Catalogue Number: 900PT561
• Device Lot Number: 2102084761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT; F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT
• Patient Sex: Unknown