MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD F&P EVAQUA 2; BREATHING CIRCUIT

Model Number	RT266
Medical Device Problem Codes	Gas/Air Leak (2946); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
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 rt266 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 healthcare facility in japan reported on behalf of another healthcare facility via a fisher & paykel (f&p) healthcare field representative that the rt266 infant dual heated evaqua2 breathing circuit failed the pre-use test.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 healthcare facility in japan reported on behalf of another healthcare facility via a fisher & paykel (f&p) healthcare field representative that the rt266 infant dual heated evaqua2 breathing circuit failed the pre-use test.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Corrections: section d1: brand name updated.Section d8: section unticked.Method: the subject rt266 infant ventilator circuit was returned to fisher & paykel (f&p) healthcare for evaluation in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned rt266 infant ventilator circuit identified no notable damage.Leak testing confirmed the presence of a leak.Further inspection of the subject device identified a gap at the duckbill slit, causing the reported leak.Conclusion: the reported leak was confirmed and was due to the damage observed on the duckbill slit of the rt266 infant ventilator circuit.The user instructions that accompany the rt266 infant ventilator circuit state: - perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.- visually inspect breathing sets for damage.- appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.

• 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: 23721540
• Report Number: 9611451-2025-01763
• Device Sequence Number: 21041614
• Product Code: BZE
• UDI-Device Identifier: 09420012431103
• UDI-Public: (01)09420012431103(10)2103665319(11)250310(17)300310
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: 2103665319
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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