MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD F&P EVAQUA 2; 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	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in china reported via a fisher & paykel (f&p) healthcare field representative that an mr290v vented autofeed humidification chamber provided as part of the rt265 dual heated infant circuit kit was found to be leaking before use.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(6).Method: the subject mr290v vented autofeed humidification chamber provided as part of the rt265 dual heated infant circuit kit was not returned to fisher & paykel (f&p) healthcare for evaluation.Our investigation is based on the information, video and description of events provided by the healthcare facility, previous investigations of similar complaints and our knowledge of the product.Results: visual inspection of the provided video observed that the mr290v vented autofeed humidification chamber provided as part of the rt265 dual heated infant circuit kit was leaking water around the base flange area, confirming the reported issue.Conclusion: without the subject device, we are unable to determine the exact cause of the reported fault.The mr290v vented autofeed humidification chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.Every mr290v vented autofeed humidification chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The subject breathing circuit kit would have met the required specifications at the time of production.The user instructions for the rt265 infant breathing circuit include the following: - do not use the chamber if the seals are not intact when received, or if it has been dropped.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- ensure there is a water supply connected to the chamber and that water is present within the chamber.- appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.- ensure appropriate ventilator or flow source alarms are set before connecting breathing sets to patient.- visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use and replace if damaged.

• Brand Name: F&P EVAQUA 2
• 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 25402626
• Report Number: 9611451-2026-01813
• Device Sequence Number: 13449655
• Product Code: BZE
• UDI-Device Identifier: 09420012430205
• UDI-Public: (01)09420012430205(10)2103820494(11)250617(17)300617
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: 2103820494
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• 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
• Patient Sex: Unknown