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	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The rt265 infant dual-heated evaqua2 breathing circuit has been requested to be returned to fisher & paykel (f&p) healthcare in new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in south africa that a rt265 infant dual heated evaqua2 breathing circuit failed the pre-use leak test.There was no patient consequence reported.
Additional Manufacturer Narrative
(b)(6).Section a1: patient identifier updated.Section d1: brand name updated.Section d2a: common device name corrected.Section d4: expiration date corrected.Section d4: udi corrected.Section h4: date of manufacture corrected.Section h11: method: the subject rt265 infant dual heated evaqua2 breathing circuit was received at fisher & paykel healthcare (f&p) in new zealand for evaluation, where it was visually inspected and leak tested.Results: visual inspection identified no damage or defects with the returned breathing circuit.Leak testing confirmed that the breathing circuit was within specification.Conclusion: we are unable to determine what may have caused the reported failed ventilator leak test, as there was no fault found with the returned device.All rt265 infant dual heated evaqua2 breathing circuits are visually inspected, as well as pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt265 infant dual heated evaqua2 breathing circuit show in pictorial format the correct set-up of the circuit and also state the following: - visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use and replace if damaged.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- check all connections are tight before use.- ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient - appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in south africa that an rt265 infant dual heated evaqua2 breathing circuit failed the pre-use leak test.There was no patient consequence reported.

• 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: 23783891
• Report Number: 9611451-2025-01977
• Device Sequence Number: 5128786
• Product Code: BZE
• UDI-Device Identifier: 09420012430205
• UDI-Public: (01)09420012430205(10)2103288105(11)240812(17)290812
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 2103288105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: AVEA VENTILATOR
• Patient Sex: Unknown