MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD F&P EVAQUA 2; 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	01/22/2026
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 circuit 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 distributor in japan reported on behalf of a healthcare facility via a fisher & paykel healthcare representative that an rt265 infant dual-heated evaqua2 breathing circuit failed the ventilator leak test prior to patient use.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 distributor in japan reported on behalf of a healthcare facility via a fisher & paykel (f&p) healthcare field representative that an rt265 infant dual-heated evaqua2 breathing circuit failed the ventilator leak test prior to patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(6).Corrections: section d1: brand name updated.Section d8: section unticked.Method: the subject rt265 infant dual-heated evaqua2 breathing circuit was returned to fisher & paykel (f&p) healthcare for evaluation in new zealand where it was visually inspected and analysed.Results: visual inspection identified no damage or defects with the returned rt265 infant dual-heated evaqua2 breathing circuit.Leak testing confirmed that the rt265 infant dual-heated evaqua2 breathing circuit was within specifications.Conclusion: we are unable to determine what may have caused the reported leak test failure, as there was no fault found with the returned device.The user instructions that accompany the rt265 infant dual-heated evaqua2 breathing circuit state the following: - perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use, and replace if damaged.- ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.

• 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 ; 9494341005
• MDR Report Key: 24381597
• Report Number: 9611451-2026-00578
• Device Sequence Number: 21488231
• Product Code: BZE
• UDI-Device Identifier: 09420012430205
• UDI-Public: (01)09420012430205(10)2103824173(11)250619(17)300619
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 2103824173
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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: PMH8000 HUMIDIFIER; PMH8000 HUMIDIFIER; PURITAN BENNETT 840 (PB840) VENTILATOR; PURITAN BENNETT 840 (PB840) VENTILATOR
• Patient Sex: Unknown