MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; 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	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in colombia reported, 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).Method: the subject rt265 infant dual-heated evaqua2 breathing circuit was not provided to fisher & paykel (f&p) healthcare new zealand for evaluation as the distribuor reported that the device had been discarded.Our investigation is therefore based on the information and video provided, and our knowledge of the product.Results: a review of the provided video confirmed that the device failed the ventilator leak test.Conclusion: based on the information provided by the healthcare facility and without the return of the subject device, we are unable to determine the cause of the reported issue.As part of design validation and verification activities, all f&p healthcare products are tested to ensure they meet documented product requirements and specifications.These requirements and specifications encompass user needs, performance requirements, international product standards as well as quality system requirements.All rt265 infant dual-heated evaqua2 breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject circuits would have met the required specifications at the time of production.The user instructions for the rt265 infant dual-heated evaqua2 breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: - check all connections are tight before use.- visually inspect breathing sets for damage (e.G.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.- 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.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• 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: 23577183
• Report Number: 9611451-2025-01414
• Device Sequence Number: 9304872
• Product Code: BZE
• UDI-Device Identifier: 09420012430205
• UDI-Public: (01)09420012430205(10)2103563227(11)250114(17)300114
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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
• Device Model Number: RT265
• Device Catalogue Number: RT265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2025
• 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: MINDRAY SV300 VENTILATOR; PURITAN BENNETT 840 VENTILATOR
• Patient Sex: Unknown