MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; BREATHING CIRCUIT

Model Number	RT265
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is in the process of completing our investigation.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A distributor in china reported on behalf of a healthcare facility that a mr290v autofeed humidification chamber as part of the rt265 infant dual-heated evaqua2 breathing circuit was found leaking from the dome.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).Corrections: section b4: date of report updated.Method: the subject mr290v autofeed humidification chamber as part of the rt265 infant dual-heated evaqua2 breathing circuit was not returned to fisher & paykel (f&p) healthcare for evaluation.Our investigation is based on the information and video provided by the customer and our knowledge of our product.Results: visual inspection observed that the subject mr290v autofeed humidification chamber as part of the rt265 infant dual-heated evaqua2 breathing circuit was connected to a non f&p-heater base and flow source.The seal between the chamber dome and base was visible, and water was seen leaking from the dome to base connection.No physical damage was visible from the provided video.Conclusion: our investigation is unable to determine the exact cause of the reported fault.The user instructions provided with the rt265 breathing circuit include the following: - "do not use the chamber if the seals are not intact of if it has been dropped." - "visually inspect breathing sets for damage (e.G.A crushed tub or cracked connector) before use and replace if damaged." - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".
Event or Problem Description
A distributor in china reported on behalf of a healthcare facility that a mr290v autofeed humidification chamber as part of the rt265 infant dual-heated evaqua2 breathing circuit was found leaking from the dome.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: BREATHING CIRCUIT
• 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: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 22191312
• Report Number: 9611451-2025-00539
• Device Sequence Number: 13088936
• Product Code: BZE
• UDI-Device Identifier: 09420012430205
• UDI-Public: (01)09420012430205(10)2103170693(11)240605(17)290605
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: RT265
• Device Catalogue Number: RT265
• Device Lot Number: 2103170693
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2024
• 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
• Patient Sex: Unknown