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

Model Number	RT265
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel (f&p) healthcare are currently in the process of obtaining further information regarding the reported event.We have also requested the return of the subject rt265 infant dual-heated evaqua2 breathing circuits to f&p healthcare new zealand for investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in switzerland reported via a fisher & paykel (f&p) healthcare field representative, that two rt265 infant dual-heated evaqua2 breathing circuits were not securely fitted to the ventilator.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 switzerland reported via a fisher & paykel (f&p) healthcare field representative, that two rt265 infant dual-heated evaqua2 breathing circuits were not securely fitted to the ventilator.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).Method: all three reported rt265 infant dual-heated evaqua2 breathing circuits were received at fisher & paykel (f&p) healthcare in new zealand for investigation, where it was visually inspected and performance tested.Our investigation is thus based on the evaluation of the subject devices, the information provided by the healthcare facility and our knowledge of the product.Results: the returned drylines were performance tested against three different ventilators (leoni plus, maquet servo-i and nellcor puritan bennet 840), all of which were able to securely connect to the inspiratory connector of the ventilators.Performance testing of the returned rt265 infant dual-heated evaqua2 breathing circuits could not replicate the reported issue.Conclusion: f&p healthcare's investigation was unable to determine the cause of the reported issue as there was no fault found with the returned devices.All rt265 infant dual-heated evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt265 infant dual-heated evaqua2 breathing circuit state the following: - "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." - "do not use the chamber if the seals are not intact when received, or if it has been dropped.".

• 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: 23248990
• Report Number: 9611451-2025-01017
• Device Sequence Number: 13372394
• Product Code: BZE
• UDI-Device Identifier: 09420012430205
• UDI-Public: (01)09420012430205(10)2103650178(11)250303(17)300303
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: 2103650178
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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: EVE NEO VENTILATOR; EVE NEO VENTILATOR
• Patient Sex: Unknown