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	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the subject mr290v vented autofeed humidification chamber provided as part of the rt265 infant dual heated evaqua2 breathing circuit was received at our fisher & paykel (f&p) healthcare regional office in china where it was visually inspected by a trained f&p healthcare service technician.The customer also provided additional information relating to the reported event upon request.Our investigation is based on the information provide by the f&p healthcare service technician, the information provided by the customer, and our knowledge of the product.Results: visual inspection of the subject mr290v vented autofeed humidification chamber at our regional office observed that the base was leaking, confirming the reported issue.Further inspection of the provided video and photograph was performed and observed that there was a crack at the base flange.The dome was also leaking water.Conclusion: without the return of the mr290v vented autofeed humidification chamber provided as part of the rt265 infant dual heated evaqua2 breathing circuit, we are unable to determine the exact cause of the reported fault.Every mr290v vented autofeed humidification chamber is pressure tested following the manufacturing process and any holes, cracks, or leaks would be identified during this process.In addition, the pressure test is followed by a visual inspection of each chamber.Any chamber which fails these tests is rejected.The subject mr290v vented autofeed humidification chamber would have met the required specifications at the time of production.The user instructions for the mr290v vented autofeed humidification chamber state the following: do not soak, wash or sterilize this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.Do not use the chamber if the seals are not intact when received, or if it has been dropped.Use of the mr290 above maximum operating pressure may lead to cracking, water leakage and, on rare occasions, could lead to a loss of ventilator pressure.Use usp sterile water for inhalation or equivalent for humidification.Do not add other substances to the water.Ensure appropriate ventilator or flow source alarms are set before connecting breathing sets to patient.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china than an mr290v autofeed humidification chamber, provided as part of an rt265 infant dual-heated evaqua2 breathing circuit, was found to be leaking before use.There was no reported patient involvement.

• 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: 25399522
• Report Number: 9611451-2026-01773
• Device Sequence Number: 13441464
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• 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