MAUDE Adverse Event Report: Fisher & Paykel Healthcare Ltd F&P Evaqua 2; Breathing Circuit

Model Number	RT266
Medical Device Problem Codes	Crack (1135); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel (f&p) healthcare field representative, that an rt266 infant dual-heated evaqua2 breathing circuit failed the pre-use ventilator leak test due to a crack on the dome of the mr290v vented autofeed humidification chamber provided with the breathing circuit kit.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4) the subject mr290v vented autofeed humidification chamber provided with the rt266 infant dual-heated evaqua2 breathing circuit has been returned to fisher & paykel (f&p) healthcare in new zealand for evaluation.A follow up report will be provided upon completion of our investigation.

• 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 banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; +1(949)434-1005
• MDR Report Key: 50877282
• Report Number: 9611451-2026-02793
• Device Sequence Number: 9314343
• Product Code: BZE
• UDI-Device Identifier: 09420012431103
• UDI-Public: (01)09420012431103(10)2104274630(11)260406(17)310406
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 2104274630
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown